Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305577953836 Date of Approval: 24/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized, multi-centric, active controlled, parallel group, open-label, comparative study to evaluate the efficacy and safety of Rabeprazole and Omeprazole in patients of gastroesophageal reflux disease (GERD)
Official scientific title A randomized, multi-centric, active controlled, parallel group, open-label, comparative study to evaluate the efficacy and safety of Rabeprazole and Omeprazole in patients of gastroesophageal reflux disease
Brief summary describing the background and objectives of the trial Study design: Randomized, multi-centric, active controlled, parallel group, open-label, comparative study This is a phase IV, randomized, parallel-group, multi-center, open label, two-arm, active-controlled, comparative study. The study will be conducted at approximately 8-10 centers in Morocco, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approval, i.e. Institutional Ethics Committees, CNDP (National Commission for Personal Data Protection Control), DMP (Directorate of Medicines and Pharmacy – MoH) Background Gastroesophageal reflux disease is a common chronic GI disorder defined as reflux of gastric contents into the esophagus that leads to troublesome symptoms (classically heartburn and regurgitation).1 Although the prevalence of gastroesophageal reflux disease in Morocco is not known due to lack of population-based studies. It is expected to be similar to the published data from other developing countries, where prevalence of gastroesophageal reflux disease varies from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies.2 In the treatment of gastroesophageal reflux disease, the usual aims are to relieve symptoms, improve the patient’s quality of life, heal mucosal lesions, and prevent recurrence and complications. The pharmacologic agents currently used for treating gastroesophageal reflux disease are the gastric anti-secretory agents. PPIs are currently the most effective agents to treat gastroesophageal reflux disease. Study Objective: A. Primary Objective: • To compare the efficacy of rabeprazole with omeprazole on proportion of patients with sustained resolution of heartburn [7 consecutive heartburn-free days (24 hour period) from baseline] at the end of Week 1 B. Secondary Objectives: • `To compare the effect of rabeprazole with omeprazole in GERD symptom relief in terms of: a. Time to onset of first heart burn free day (intensity = 0) b. Time
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/12/2023
Actual trial start date
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 486
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Test arm Test arm: One tablet of 20 mg rabeprazole orally, once daily, in the morning, before breakfast for 4 weeks After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will take the study medication for 4 weeks (Treatment period). Patients will be either randomized to Test arm (One tablet of 20 mg rabeprazole once daily) 243
Control Group Comparator arm • Comparator arm: One capsule of 20 mg omeprazole orally, once daily, in the morning, before breakfast for a duration of 4 weeks. 4 Weeks After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will take the study medication for 4 weeks (Treatment period). Patients will be either randomized to Comparator arm (One capsule of 20 mg omeprazole once daily). During the study, assessments will be performed as mentioned in Schedule of Assessment. 243 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Subjects of either gender aged 18 to 65 years • History of gastroesophageal reflux disease (GERD) symptoms (Heartburn ± Regurgitation) for at least 1 month immediately before screening • Heartburn for at least 3 days a week for at least 2 weeks preceding the screening • Willing to provide written informed consent • Women of reproductive age group willing to use an acceptable method of contraception during the conduct of the study • Active gastric or duodenal ulcer; • Known case of Zollinger Ellison syndrome or Gastrointestinal malignancy • History of oesophageal or gastric surgery or primary oesophageal motility disorder • Active treatment or history of treatment in last 1 month with proton pump inhibitors, H2 blockers or prokinetic drugs • Pregnancy or breast-feeding • Impaired hepatic or renal function; uncontrolled diabetes mellitus or hypertension • Anticoagulation therapy or clotting disorders • Alcoholism or drug abuse • Severe concomitant cardiovascular, hepatic, renal, pulmonary, malignant or haematological disease • Subjects deemed inappropriate by investigator • Patient with “alarm features” in symptomatology, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool, pointing to a possible malignant disease of the GI tract. • Surgical or medical condition that, in the judgement of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the study drugs. • Patient with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV). • Participation in another clinical trial in the past 3 months or planning to participate in another clinical trial during the study • Patients having hypersensitivity or any other contraindication to any of the Investigational products or its component. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/03/2023 fondation cheikh zaid
Ethics Committee Address
Street address City Postal code Country
Avenue Allal Al Fassi, Rabat 10000, Maroc Rabat 10000 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • Proportion of patients with sustained resolution of heartburn [7 consecutive heartburn-free days (24 hour period) from baseline] at the end of Week 1 24 hours
Secondary Outcome • Time to onset of first heart burn free day (intensity = 0) [Time frame: Wk 1] • Time to onset of relief of heartburn (intensity ≤1) [Time frame: Wk 1] • Proportion of patients who are heart burn free (Intensity =0 at day time and night time) at Day 2 and at EOT [Time frame: Day 2, Wk 1, 2 & 4] • Proportion of patients with satisfactory relief from heartburn (intensity ≤1) [Time frame: Wk 1, 4] • Proportion of heartburn free days (daytime and nighttime intensity =0) [Time frame: Wk 1 & 4] • Proportion of Days without day time heartburn [Time frame: Wk 1 & 4] • Proportion of Days without night time heartburn [Time frame: Wk 1 & 4] • Reduction in heartburn and regurgitation score [Time frame: Wk 1 & 4] • Change in the CGI-I from baseline [Time frame: Wk 1& 4] • Proportion of responders (Very much improved, or much improved) as per CGI-Improvement Scale [Time frame: Wk 1& 4] • Proportion of patients using rescue medication [Time frame: Wk 1& 4] • Percentage of days without rescue medication [Time frame: Wk 1& 4] • Proportion of participants with adverse events (AEs) and serious adverse events (SAEs) [Time frame: 4 weeks] week 1 and 4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr Chbihi Fouad Meknes Meknes 10 000 Morocco
Dr Anis Balafrej Rabat Hassan Rabat 10000 Morocco
Dr Hamoud Abdellah Nador Nador 20200 Morocco
Dr Semmar Khalid Tanger tanger 13000 Morocco
Dr Benhayoun Mohamed Abdelmoumen Casablanca Casablanca 20200 Morocco
Dr Said el jastimi Guiliz Marrakech Marrakech 14000 Morocco
Dr Kanouni Nawal centre ville Rabat Rabat 10000 Morocco
Dr Zizzi Mohamed Oujda Oujda 150000 Morocco
Pr Driss Jamil Maarif Casablanca Casablanca 10200 Morocco
Dr Abdelaziz Ziane Casablanca Anfa casablanca 10120 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
SUN PHARMA Bd Zerktouni,Angle Bd Roudani Casablanca 20330 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SUN PHARMA angle Bd Zerktouni Bd Roudani casablanca 20330 Morocco Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator fatima zohra ajana ajafatimz@yahoo.fr 00212661540101 CHU ibno sina
City Postal code Country Position/Affiliation
rabat 10000 Morocco Head of gastroenterology department in rabat university hospital
Role Name Email Phone Street address
Scientific Enquiries ghizlane tahri tahri.ghizlane@sunpharma.com 00212620201226 angle Bd Zerktouni Bd Roudani
City Postal code Country Position/Affiliation
casablanca 20330 Morocco medical advisor
Role Name Email Phone Street address
Public Enquiries sameer Rao Sameer.Rao@sunpharma.com +919820097063 SUN HOUSE Western Express Highway Goregaon
City Postal code Country Position/Affiliation
Mumbai 390012 India General manager medical affairs and clinical trials
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article after de-identification will be shared with researchers or regulators upon request after providing a methodologically sound proposal. The information would be available beginning 3 months and ending 2 years after publication. The information would be available beginning 3 months and ending 2 years after publication. Study Protocol March 2024 CRO main investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 22/05/2023 to explain what GERD stands for A randomized, multi-centric, active controlled, parallel group, open-label, comparative study to evaluate the efficacy and safety of Rabeprazole and Omeprazole in patients of GERD A randomized, multi-centric, active controlled, parallel group, open-label, comparative study to evaluate the efficacy and safety of Rabeprazole and Omeprazole in patients of gastroesophageal reflux disease (GERD)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 22/05/2023 to explain what GERD stands for A randomized, multi-centric, active controlled, parallel group, open-label, comparative study to evaluate the efficacy and safety of Rabeprazole and Omeprazole in patients of GERD A randomized, multi-centric, active controlled, parallel group, open-label, comparative study to evaluate the efficacy and safety of Rabeprazole and Omeprazole in patients of gastroesophageal reflux disease
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 17/04/2023 add information regarding the main objectives and a brief background about the study Study design: Randomized, multi-centric, active controlled, parallel group, open-label, comparative study This is a phase IV, randomized, parallel-group, multi-center, open label, two-arm, active-controlled, comparative study. The study will be conducted at approximately 8-10 centers in Morocco, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approval, i.e. Institutional Ethics Committees, CNDP (National Commission for Personal Data Protection Control), DMP (Directorate of Medicines and Pharmacy – MoH) Study design: Randomized, multi-centric, active controlled, parallel group, open-label, comparative study This is a phase IV, randomized, parallel-group, multi-center, open label, two-arm, active-controlled, comparative study. The study will be conducted at approximately 8-10 centers in Morocco, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approval, i.e. Institutional Ethics Committees, CNDP (National Commission for Personal Data Protection Control), DMP (Directorate of Medicines and Pharmacy – MoH) Background Gastroesophageal reflux disease is a common chronic GI disorder defined as reflux of gastric contents into the esophagus that leads to troublesome symptoms (classically heartburn and regurgitation).1 Although the prevalence of GERD in Morocco is not known due to lack of population-based studies. It is expected to be similar to the published data from other developing countries, where prevalence of GERD varies from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies.2 In the treatment of GERD, the usual aims are to relieve symptoms, improve the patient’s quality of life, heal mucosal lesions, and prevent recurrence and complications. The pharmacologic agents currently used for treating GERD are the gastric anti-secretory agents. PPIs are currently the most effective agents to treat GERD. Study Objective: A. Primary Objective: • To compare the efficacy of rabeprazole with omeprazole on proportion of patients with sustained resolution of heartburn [7 consecutive heartburn-free days (24 hour period) from baseline] at the end of Week 1 B. Secondary Objectives: • `To compare the effect of rabeprazole with omeprazole in GERD symptom relief in terms of: a. Time to onset of first heart burn free day (intensity = 0) b. Time to onset of relief of heartburn (intensity ≤1) c. Proportion of patients who are heart burn free (Intensity =0 at day time and night t
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 22/05/2023 to explain what GERD stands for Study design: Randomized, multi-centric, active controlled, parallel group, open-label, comparative study This is a phase IV, randomized, parallel-group, multi-center, open label, two-arm, active-controlled, comparative study. The study will be conducted at approximately 8-10 centers in Morocco, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approval, i.e. Institutional Ethics Committees, CNDP (National Commission for Personal Data Protection Control), DMP (Directorate of Medicines and Pharmacy – MoH) Background Gastroesophageal reflux disease is a common chronic GI disorder defined as reflux of gastric contents into the esophagus that leads to troublesome symptoms (classically heartburn and regurgitation).1 Although the prevalence of GERD in Morocco is not known due to lack of population-based studies. It is expected to be similar to the published data from other developing countries, where prevalence of GERD varies from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies.2 In the treatment of GERD, the usual aims are to relieve symptoms, improve the patient’s quality of life, heal mucosal lesions, and prevent recurrence and complications. The pharmacologic agents currently used for treating GERD are the gastric anti-secretory agents. PPIs are currently the most effective agents to treat GERD. Study Objective: A. Primary Objective: • To compare the efficacy of rabeprazole with omeprazole on proportion of patients with sustained resolution of heartburn [7 consecutive heartburn-free days (24 hour period) from baseline] at the end of Week 1 B. Secondary Objectives: • `To compare the effect of rabeprazole with omeprazole in GERD symptom relief in terms of: a. Time to onset of first heart burn free day (intensity = 0) b. Time to onset of relief of heartburn (intensity ≤1) c. Proportion of patients who are heart burn free (Intensity =0 at day time and night t Study design: Randomized, multi-centric, active controlled, parallel group, open-label, comparative study This is a phase IV, randomized, parallel-group, multi-center, open label, two-arm, active-controlled, comparative study. The study will be conducted at approximately 8-10 centers in Morocco, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and Ethics committee (EC) approval, i.e. Institutional Ethics Committees, CNDP (National Commission for Personal Data Protection Control), DMP (Directorate of Medicines and Pharmacy – MoH) Background Gastroesophageal reflux disease is a common chronic GI disorder defined as reflux of gastric contents into the esophagus that leads to troublesome symptoms (classically heartburn and regurgitation).1 Although the prevalence of gastroesophageal reflux disease in Morocco is not known due to lack of population-based studies. It is expected to be similar to the published data from other developing countries, where prevalence of gastroesophageal reflux disease varies from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies.2 In the treatment of gastroesophageal reflux disease, the usual aims are to relieve symptoms, improve the patient’s quality of life, heal mucosal lesions, and prevent recurrence and complications. The pharmacologic agents currently used for treating gastroesophageal reflux disease are the gastric anti-secretory agents. PPIs are currently the most effective agents to treat gastroesophageal reflux disease. Study Objective: A. Primary Objective: • To compare the efficacy of rabeprazole with omeprazole on proportion of patients with sustained resolution of heartburn [7 consecutive heartburn-free days (24 hour period) from baseline] at the end of Week 1 B. Secondary Objectives: • `To compare the effect of rabeprazole with omeprazole in GERD symptom relief in terms of: a. Time to onset of first heart burn free day (intensity = 0) b. Time
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 12/03/2025 We started recruiting patients Active, not recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/04/2023 to remove from description the part related to comparator Experimental Group, Test arm, Test arm: One tablet of 20 mg rabeprazole orally, once daily, in the morning, before breakfast for, 4 weeks, After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will take the study medication for 4 weeks (Treatment period). Patients will be either randomized to Test arm (One tablet of 20 mg rabeprazole once daily) , 243,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/04/2023 to remove information on the test group Control Group, Comparator arm, • Comparator arm: One capsule of 20 mg omeprazole orally, once daily, in the morning, before breakfast for a duration of 4 weeks., 4 Weeks, After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will take the study medication for 4 weeks (Treatment period). Patients will be either randomized to Comparator arm (One capsule of 20 mg omeprazole once daily). During the study, assessments will be performed as mentioned in Schedule of Assessment., 243, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/04/2023 to remove the information on the test group Control Group, Comparator arm, • Comparator arm: One capsule of 20 mg omeprazole orally, once daily, in the morning, before breakfast for a duration of 4 weeks., 4 Weeks, After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will take the study medication for 4 weeks (Treatment period). Patients will be either randomized to Test arm (One tablet of 20 mg rabeprazole once daily) OR to Comparator arm (One capsule of 20 mg omeprazole once daily). During the study, assessments will be performed as mentioned in Schedule of Assessment., 243, Active-Treatment of Control Group Control Group, Comparator arm, • Comparator arm: One capsule of 20 mg omeprazole orally, once daily, in the morning, before breakfast for a duration of 4 weeks., 4 Weeks, After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will take the study medication for 4 weeks (Treatment period). Patients will be either randomized to Comparator arm (One capsule of 20 mg omeprazole once daily). During the study, assessments will be performed as mentioned in Schedule of Assessment., 121, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 17/04/2023 add the names of the 10 centers CIC, Cheikh Zaid Foundation, Avenue Allal El fassi, Madinat Al Irfane, Hay Riad, Rabat, 10 000, Morocco 10 gastroenterologists clinics Dr Chbihi Fouad Dr Anis Balafrej Dr Hamoud Abdellah Dr Semmar Khalid Dr Benhayoun Mohamed kamal Dr Said el jastimi Dr Kanouni Nawal Dr Zizzi Mohamed Pr Driss Jamil Dr Abdelaziz Ziane, Meknes Rabat Nador Tanger Casablanca Marrakech Rabat Oujda Casablanca Casablanca, Rabat, 10 000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 to name each center individually 10 gastroenterologists clinics Dr Chbihi Fouad Dr Anis Balafrej Dr Hamoud Abdellah Dr Semmar Khalid Dr Benhayoun Mohamed kamal Dr Said el jastimi Dr Kanouni Nawal Dr Zizzi Mohamed Pr Driss Jamil Dr Abdelaziz Ziane, Meknes Rabat Nador Tanger Casablanca Marrakech Rabat Oujda Casablanca Casablanca, Rabat, 10 000, Morocco Dr Chbihi Fouad , Meknes Rabat Nador Tanger Casablanca Marrakech Rabat Oujda Casablanca Casablanca, Rabat, 10 000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 to name each center individually Dr Chbihi Fouad , Meknes Rabat Nador Tanger Casablanca Marrakech Rabat Oujda Casablanca Casablanca, Rabat, 10 000, Morocco Dr Chbihi Fouad , Meknes , Meknes , 10 000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 To list each center on it's own Dr Anis Balafrej , Rabat Hassan, Rabat , 10000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 TO LIST EACH CENTER ON IT'S Own Dr Hamoud Abdellah , Nador, Nador, 20200, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 to list each center individually Dr Semmar Khalid , Tanger, tanger , 13000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 TO list each center individually Dr Benhayoun Mohamed , Abdelmoumen Casablanca, Casablanca, 20200, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 to list each center individually Dr Said el jastimi , Guiliz Marrakech, Marrakech , 14000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 to list each center individually Dr Kanouni Nawal , centre ville Rabat, Rabat, 10000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 TO LIST EACH CENTER INDIVIDUALLY Dr Zizzi Mohamed , Oujda , Oujda , 150000, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 to list each center on it's own Pr Driss Jamil , Maarif Casablanca , Casablanca , 10200, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 22/05/2023 to list it's center on it's own Dr Abdelaziz Ziane, Casablanca Anfa , casablanca , 10120, Morocco
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 17/04/2023 write your Individual patient data (IPD) Sharing Statement After confirming the eligibility, patients will be randomized by allotting the randomization number. The randomized patients will take the study medication for 4 weeks (Treatment period). Patients will be either randomized to Test arm (One tablet of 20 mg rabeprazole once daily) OR to Comparator arm (One capsule of 20 mg omeprazole once daily). During the study, assessments will be performed as mentioned in Schedule of Assessment. The study consists of following visits: Visit 1 (Day 1), Week 1: Screening Visit, Enrollment, Randomization, Baseline Visit Visit 2 (Day 7+2), Week 1: Physical Visit Visit 3 (Day 14 ± 2) Week 2: Telephonic Follow up 1 Visit 4 (Day 21 ± 2) Week 3: Telephonic Follow up 2 Visit 3 (Day 28 ± 4) Week 4: End of Study Visit (EOS)/End of Treatment (EOT) Visit/ Early Termination (ET) Visit Patients will be provided with diary to record details about study drug administration, rescue medication, heartburn events, regurgitation events and adverse events. Patients will be required to bring completed diary and empty strips as a proof of compliance at second and third visit. Patients discontinuing early from the study will be completing Visit 2 assessments. Visit 2 will be considered as EOS Visit/EOT Visit/ET Visit. The efficacy and safety will be assessed during the study period. To ensure completeness and accuracy of CRFs, the study will be monitored by designated Clinical Study Monitor. Site master file will be established at each site at the time of study initiation. The Principal Investigator will maintain study documents as specified in the ICH GCP guidelines and as required by the applicable regulatory requirements. Principal Investigator will take measures to prevent accidental or premature destruction of these documents. Principal Investigator will permit the study related monitoring, audits and regulatory inspection providing direct access to source data/documents. Study monitor will visit the study centers at regular intervals, the frequency of which will vary depending on the recruitment rate. The first monitoring visit will be conducted after the first few patients are enrolled. It is the duty of the Investigator to provide open access to the monitor of all study related records at previously agreed time. The Sponsor, IEC and Regulatory Authorities shall have right to direct access to source data for verification. Information that can identify study patients will be kept confidential and managed according to the requirements of the applicable law(s) of the respective country. Patient authorization to collect protected health information (PHI) will be a part of informed consent process. In the event that a patient revokes authorization to collect or use PHI, the Investigator, by regulation, retains the ability to use all information collected prior to the revocation of patient authorization. For patients that have revoked authorization to collect or use PHI, attempts should be made to obtain permission to collect at least safety information at the end of their scheduled study period.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 20/05/2023 as per the PACTR request To ensure completeness and accuracy of CRFs, the study will be monitored by designated Clinical Study Monitor. Site master file will be established at each site at the time of study initiation. The Principal Investigator will maintain study documents as specified in the ICH GCP guidelines and as required by the applicable regulatory requirements. Principal Investigator will take measures to prevent accidental or premature destruction of these documents. Principal Investigator will permit the study related monitoring, audits and regulatory inspection providing direct access to source data/documents. Study monitor will visit the study centers at regular intervals, the frequency of which will vary depending on the recruitment rate. The first monitoring visit will be conducted after the first few patients are enrolled. It is the duty of the Investigator to provide open access to the monitor of all study related records at previously agreed time. The Sponsor, IEC and Regulatory Authorities shall have right to direct access to source data for verification. Information that can identify study patients will be kept confidential and managed according to the requirements of the applicable law(s) of the respective country. Patient authorization to collect protected health information (PHI) will be a part of informed consent process. In the event that a patient revokes authorization to collect or use PHI, the Investigator, by regulation, retains the ability to use all information collected prior to the revocation of patient authorization. For patients that have revoked authorization to collect or use PHI, attempts should be made to obtain permission to collect at least safety information at the end of their scheduled study period. Individual participant data that underlie the results reported in this article after de-identification will be shared with researchers or regulators upon request after providing a methodologically sound proposal. The information would be available beginning 3 months and ending 2 years after publication. The information would be available beginning 3 months and ending 2 years after publication.