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.: PACTR202311905202771 Date of Approval: 08/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Efficacy and Safety of Polygel Dual and Other Antacids in the Treatment of Heartburn and Dyspepsia
Official scientific title Comparative Efficacy and Safety of Polygel Dual and Other Antacids in the Treatment of Heartburn and Dyspepsia: A Randomized Double-Blind Controlled Study
Brief summary describing the background and objectives of the trial Heartburn and indigestion (dyspepsia) are common medical complaints that the patients always seek immediate relief from pain/discomfort first before any further medical consultation and evaluation. The three most common conditions that cause dyspepsia in Nigeria are Gastro Esophageal Reflux Disease (GERD), Peptic Ulcer Disease (PUD) and Functional Dyspepsia (FD).Various antacids with similar but slightly different active ingredients/excipients and acid neutralizing capacity have been developed over the years with the singular aim of developing an “ideal” antacid that can give patients with heartburn/dyspepsia rapid symptom relief with minimal or no adverse effects. The growing number of antacid preparations in the Nigerian drug market has made it necessary upon practitioners who directly deal with these patients to scientifically and ethically study the many available antacids in order to scientifically assess their relative efficacies in relieving heartburn and dyspepsia symptoms. Polygel Dual is an antacid preparation that has been studied in vitro with encouraging results. The results of this in vitro study of Polygel Dual have made it necessary to study and compare the in vivo effect(s) of the preparation in heartburn and dyspeptic patients in comparison to commonly available alignate-based antacid products from the Nigerian market. Primary Objective: 1. Change from baseline in Reflux Disease Questionnaire (RDQ) scores for GERD (heartburn and regurgitation) dimension and RDQ scores for dyspepsia dimension at day 2, day 7 and day 14 Secondary Objectives: 1. To assess the onset of relief of symptoms 2. To assess the duration of relief of symptoms 3. Global Assessment of patients and physicians’ satisfaction with the efficacy, rapidity of action and tolerability of the product 4. Palatability of the product will also be assessed 5. To assess adverse events during study duration
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BARIER
Disease(s) or condition(s) being studied Heartburn and Dyspepsia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/11/2023
Actual trial start date 02/11/2023
Anticipated date of last follow up 15/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
SHL PD 01 0323 Shalina Healthcare Nigeria Limited
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Polygel Dual 15 ml TID Morning 8 am after Breakfast Afternoon 1 pm after Lunch Night at 8 pm after Dinner 14 Days Polygel Dual (Dried aluminum hydroxide gel 254 mg + Magnesium carbonate 237.5 mg + Sodium alginate 250 mg + simethicone 50mg/5 ml) 60
Control Group Antacid 1 15 ml BD Morning 8 am after Breakfast Night at 8 pm after dinner 14 Days (Dried aluminum hydroxide 250 mg + Magnesium hydroxide 250 mg + Magnesium trisilicate 250 mg + Alginic acid 200 mg + Activated dimethicone 125 mg/15 ml) 60 Active-Treatment of Control Group
Control Group Antacid 2 15 ml TID Morning 8 am after Breakfast Afternoon 1 pm after Lunch Night at 8 pm after Dinner 14 Days (Sodium bicarbonate 267 mg + Calcium carbonate 160 mg + Sodium alginate 500 mg/10 ml) 60 Active-Treatment of Control Group
Control Group Antacid 3 10 ml TID morning 8 am after Breakfast Afternoon 1 pm after Lunch Night at 8 pm after Dinner 14 Days (Aluminum hydroxide 365 mg + Magnesium hydroxide 80 mg + Simethicone 100 mg + Deglycyrrhizinated liquorice 400 mg) 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Patients suffering from heartburn and/or regurgitation (more than 2 weekly episodes of heartburn) and indigestion. 2.Patients of both sexes who are 18 years and above. 3.Patients not on proton pump inhibitors (PPI) or H2-receptor antagonists in 7 days or any other antacids in the last 3 days 4.Patients willing to provide written informed consent 1.Contraindications for the ingredients present in Polygel Dual and other study medications as per approved local prescribing information. 2.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study. 3.Pregnant or nursing women 4.Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) or steroids. 5.Patients with confirmed organic disease at upper GI endoscopy. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 17/10/2023 Aminu Kano Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zaria Road Kano 700101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1.Change from baseline in Reflux Disease Questionnaire (RDQ) scores for GERD (heartburn and regurgitation) dimension and RDQ scores for dyspepsia dimension at day 2, day 7 and day 14 Day 2, Day 7 and Day 14
Secondary Outcome 1.To assess the onset of relief of symptoms (Less than 5 min, 5- 10 min, 10-20 min, 20-30 min, more than 30 min) 2.To assess the duration of relief of symptoms (Less than 30 min, 30 min – 1 hr, 1-2 hr, 2-3 hr, 3-4 hr) 3.Global Assessment of patients and physicians’ satisfaction with the efficacy, rapidity of action and tolerability of the product (0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good) 4.Palatability: Palatability of the product will also be assessed using the following scale (0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good) 5.To assess adverse events during study duration Look at additional comments in outcome section
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital No. 1 Zaria Road Kano 700101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Shalina Healthcare Nigeria Limited 19, Fatai Atrey Way, Matori , Mushin Lagos 102215 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shalina Healthcare Nigeria Limited 19, Fatai Atrey Way, Matori , Mushin Lagos 102215 Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samaila Adamu samailaaa@yahoo.com +2348061310534 No. 1 Zaria Road
City Postal code Country Position/Affiliation
Kano 700101 Nigeria Head Gastroenterology Unit Department of Medicine
Role Name Email Phone Street address
Public Enquiries Sanjay Dubey Sanjay.Dubey@shalina.com +2349068644110 19, Fatai Atrey Way, Matori, Mushin
City Postal code Country Position/Affiliation
Lagos 102215 Nigeria Clinical Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Kushal Sarda kushal.sarda@shalina.com +919890989871 804, Naman Centre, G Block, Bandra Kurla Complex, Bandra East,
City Postal code Country Position/Affiliation
Mumbai 400051 India General Manager and Head Medical Affairs
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 deidentification (text, tables,figures, and appendices) will be shared through a publication in a scientific medical journal and or through a presentation in a health oriented conference and professional educational forums. Clinical Study Report,Informed Consent Form,Study Protocol The data will be shared through publication and it will be accessible immediately after publication with no end date. The data will be shared in a form of publication in a medical scientific journal, therefore it will be accessible to all healthcare professionals as well as common public
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