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.: PACTR201403000694398 Date of Approval: 02/11/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Racecadotril For The Treatment Of Acute Watery Diarrhoea In Children. A Randomised Double Blinded Placebo Controlled Trial
Official scientific title Racecadotril For The Treatment Of Acute Watery Diarrhoea In Children Admitted to the Kenyatta national Hopital. A Randomised Double Blinded Placebo Controlled Trial
Brief summary describing the background and objectives of the trial Diarrhoeal disease in Kenya is the second most common cause of death in children under 5 years of age. Treatment consists of oral rehydration solution, elemental zinc and continued feeding. Racecadotril, an enkephalinase inhibitor has been used for over 2 decades in parts of europe. Few trials have been done testing its efficacy, none incorporating zinc in the treatment. This study aims to measure the efficacy of racecadotril in the treatment of severe acute gastroenteritis in children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Acute Gastroenteritis,Digestive System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/02/2014
Actual trial start date 05/02/2014
Anticipated date of last follow up 14/03/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
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
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation, variable block size 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 Racecadotril +standard WHO treatment ( ORS, Zinc, continued feeding) 1.5mg /KG stat then three times a day till formed stools seen, maximum 5 days participants will be started o standard treatment regimen by the admitting physicians, once enrolled into the study they will recieve racecadotril/placebo at 1.5 mg/kg/dose stat and then three times a day. the will be followed up with interviews and clinical examination once daily till end of teatment, either stools formed, or maximum duration (5 days reached) 60 Placebo
Control Group Placebo + Standard WHO treatment ( ORS, Zinc, Continued feeding) same amount as drug (1.5 mg/Kg) same as drug group ( till formed stools seen or maximum duration as per drug) as per drug 60 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children 3mo ¿ 60mo Acute gastroenteritis as defined by WHO (the passage of unusually loose or watery stools, usually at least three times in a 24 hour period) requiring admission for severe gastroenteritis (as evidenced by a vesicari score of >11) parental consent obtained Scoring 3 on the vesicari score for Maximum Number Vomiting Episodes per Day Clinical diagnosis of dysentery Requiring / having been prescribed antibiotics and/or probiotics or any other anti-diarrhoeal medication for the disease (except zinc) known diagnosis of liver and renal failure 3 Month(s) 60 Month(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
No 22/10/2013 Aga Khan University Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Road Nairobi 00100 Kenya
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 24/01/2014 Kenyatta NAtional Hospital / University of Nairobi Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road, Upper hill, Nairobi Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome severity of the diarrhoeal illness, measured by the number of stools in the first 48 hours after introduction of the drug and the consistency of stools at 48 hours 48 hours after introduction of the drug
Secondary Outcome the duration of inpatient stay measured as the number of hours from admission to the ward to the point discharge as determined by the attending physician, selected arbitrarily as 9.00am on the date of discharge
Secondary Outcome number of adverse events associated with racecadotril daily during the use of the drug
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Hospital road, Upper Hill Nairobi 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital Nairobi 3rd Parklands Avenue Nairobi 00100 Kenya
Sai Pharmaceuticals WHITEFIELD PLACE, UNIT C1, SCHOOL LANE WESTLANDS Nairobi 00800 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Sai Pharmaceuticals WHITEFIELD PLACE, UNIT C1, SCHOOL LANE WESTLANDS Nairobi 00800 Kenya Commercial Sector/Industry
Primary Sponsor Aga Khan University 3rd Parklands Avenue Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Aga Khan University 3rd Parklands Avenue Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jaspreet Singh Gharial jaspreet.singh@aku.edu +254 722 690 453 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya 3rd year postgraduate resident
Role Name Email Phone Street address
Public Enquiries Jaspreet Singh Gharial jaspreet.singh@aku.edu +254 722 690 453 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya 3rd year postgraduate resident
Role Name Email Phone Street address
Scientific Enquiries Fred Were frednwere@gmail.com +254 722 718 770 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Professor, Aga Khan University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Laving welltoto@gmail.com +254 724 644 122 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Honorary Faculty Aga Khan University, Lecturer University of Nairobi
REPORTING
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Result URL Hyperlinks
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