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.: PACTR202106780884401 Date of Approval: 21/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ASSESSMENT OF A NOVEL FIXED DOSE COMBINATION (FDC) DRUG VR-AD-1005 FOR THE TREATMENT OF ACUTE WATERY DIARRHEA IN CHOLERA: A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLINDED EFFICACY AND SAFETY TRIAL
Official scientific title ASSESSMENT OF A NOVEL FIXED DOSE COMBINATION (FDC) DRUG VR-AD-1005 FOR THE TREATMENT OF ACUTE WATERY DIARRHEA IN CHOLERA: A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE-BLINDED EFFICACY AND SAFETY TRIAL
Brief summary describing the background and objectives of the trial This study is a phase II, multicenter, randomized, placebo-controlled, double-blinded efficacy and safety trial. The study is designed for the assessment of a novel fixed-dose combination (FDC) drug VR-AD-1005 for the treatment of acute watery diarrhea in cholera.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Acute watery diarrhea in cholera
Purpose of the trial Treatment: Drugs
Anticipated trial start date 08/08/2021
Actual trial start date
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Suspended
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo Initially, 3 doses at time zero followed by 1 dose every 3 hours, 6 times a day. 5 days. oral tablet 150 Active-Treatment of Control Group
Experimental Group VRAD1005 Initially, 3 doses at time zero followed by 1 dose every 3 hours, 6 times a day. 5 days oral tablet 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Signed informed consent. • Adults, both genders aged 18-55 years • Acute is mild to severe watery diarrhea (defined as the passage of three or more liquid stools within the 24 hours before admission, WHO severity assessment criteria. Diarrhea is defined as severe if the patient is passing over 8 liters of stool per day, as moderate if stool output is between 3 and 8 liters per day and as mild if the patient is passing less than 3 liters of stool per day). • Confirmation of cholera detection of cholera by rapid detection test (RDT), followed by confirmation via culture or RT-PCR (as available). • Known or suspected hypersensitivity to trial product(s) or related products • Subjects with the passage of bloody stools or purulent stools • Subjects with chronic diarrhea • Clinically significant concomitant systemic disease (i.e. heart failure, acute kidney injury, sepsis or life-threatening malignant cancer) • Subjects suffering from CV abnormalities. • Mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation. • History of receiving antimicrobial or antidiarrheal drugs prior to admission. • Positive urine pregnancy test for all female patients • Failure to obtain informed consent. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 55 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 16/08/2021 Ethics Review Committee Research and Development Division
Ethics Committee Address
Street address City Postal code Country
P. O. Box MB 190 Accra P. O. Box Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in stool output volume (ml/hour) over a treatment period measured and plotted as total stool output during 12-hour stool collection every 12 hours fo120 hours. 120 hours
Secondary Outcome • Time until the stool volume output of 200mL/hour or less. Duration of stool output in excess of 200mL/hour per patient will be recorded between the start and end of the treatment for both treatment groups. • Time until recovery. Duration of diarrhea until the passage of first non-watery stool or no stool for 12 hours or the end of treatment (120 hours) will be derived from date and time records in daily stool charts. • Number of recovered subjects within the treatment group. The number of recovered subjects will be recorded as total for the entire treatment duration, and as the number of recoveries per each 24-hour period of treatment. • Number of unscheduled IV rehydration episodes per treatment. The number of unscheduled IV rehydration episodes per treatment will be recorded for the entire duration of the treatment. • Duration of IV rehydration for the entire treatment period per treatment group and per each 24-hour period of treatment. • Safety will be measured by the proportion of patients that will present with AE following administration of VR-AD-1005. 120 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pentecost Hospital Box 16122 Madina Box 16122 Ghana
Madina Polyclinic Kekele P.O. BOX MBO 186 Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Vanessa Research Holdig Inc 925 Sherman Avenue Hamden CT 06514 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Vanessa Research Holdings Inc. 925 Sherman Avenue Hamden CT 06514 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator dr. Ernest Kenu ernest_kenu@yahoo.com 026259212 Box LG 13, Legon
City Postal code Country Position/Affiliation
Accra Ghana epidemiologist
Role Name Email Phone Street address
Public Enquiries Apatu Nana Abena Kwaa ethics.research@ghsmail.org 050359896 P. O. Box MB 190
City Postal code Country Position/Affiliation
Accra Ghana GHS ERC Administrator
Role Name Email Phone Street address
Scientific Enquiries Kravtsov Dmitry vrregulatory@vanessaresearch.com +12036404315 925 Sherman Avenue
City Postal code Country Position/Affiliation
Hamden CT 06514 United States of America Vice President Research and Development
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In a clinical trial, Personal Data, which means different types of information collected or processed, and usually includes: • All general information about you, such as your name, address, and your date of birth (as defined by the local Data Protection Act) • Your information, i.e. data collected during the study, data about your illness, study evaluations or information from the analysis of your biological samples, your medical information, such as medications they normally take, and comments on their medical images. • Biological samples of your as described in the section " Purpose and execution of the study ". During the study sponsored by Vanessa Research Holdings Inc., the study physician will collect your personal data, but general information about you other than the date/year of birth and gender, as obtained by Vanessa Research Holding Inc., will be kept confidential and will not be shared with any third party. The study doctor will replace general information about you, i.e. your name and date of birth and gender, with a special code that identifies you. By associating this code with study information and biological samples, the study doctor will ensure that no one can identify you. This code, along with your work information and biological samples, will be used by the Sponsor and its representatives in accordance with the objectives and conditions described in this document and to help determine whether the treatment of work is safe and effective. In summary, Vanessa Research Holding Inc. will receive the following encoded personal data from your study doctor for the purposes of working: • Date of birth, gender, and code • Study-related Information Informed Consent Form 2 years As described above and unless required by law, your name, address, and other general information about you which is shared with Vanessa Research Holding Inc will not be shared and will be securely maintained by the team and will only be explained to the following persons or organizations: • Your study doctor and staff and authorized representatives of the clinic • Ethics Committees • Health Authorities such as the Ghana Food and Drug Agency • Vanessa Research Holdings Inc - or authorized viewers and supervisors. They are required to keep encoded personal data confidential due to their work or because they have signed confidential agreements
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information