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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: www.pactr.org

Trial no.: PACTR201211000440194 Date registered: 2012/10/21
TRIAL DESCRIPTION
Public title A comparison of triple therapy drug regimen duration for the eradication of Helicobacter pylori in adults attending a Nairobi gastroenterology clinic
Official scientific title A comparison of triple therapy drug regimen duration for the eradication of Helicobacter pylori in adults attending a Nairobi gastroenterology clinic; a randomized clinical trial
Brief summary describing the background
and objectives of the trial
Duration of Helicobacter pylori (H.pylori)treatment is usually for one or two weeks. Studies in developed countries have shown equal or increased efficacy with two week triple therapy, but no study has been done to establish this in Kenya. The aim of this study was to compare efficacy of one and two week triple therapy for H. pylori eradication in Kenya.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2007-12-03
Actual trial start date 2007-12-03
Anticipated date of last follow up 2009-12-04
Actual date of last follow up 2009-12-18
Anticipated target sample size (number of participants) 114   
Actual target sample size (number of participants) 150   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
SSC protocol no. 1317 KEMRI, Nairobi

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
Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously Randomised Simple randomisation using a randomisation table created by a computer software program sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Triple therapy - Esomeprazole, amoxicillin, clarithromycin (EAC) 20 mg esomeprazole, 1 g amoxicillin and 500mg of clarithromycin, 2x a day for 1 wk followed by 1 wk of esomeprazole 20 mg, 2x daily and amoxicillin and clarithromycin placebos(EAC1) two weeks treatment of Helicobacter pylori 76 Placebo
Control group Triple therapy - Esomeprazole, amoxicillin, clarithromycin (EAC) 20 mg esomeprazole, 1 g amoxicillin and 500mg of clarithromycin, 2x a day for 2 weeks (EAC2) two weeks treatment of Helicobacter pylori 74 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Presence of at least two of the following symptoms; upper abdominal pain or discomfort, bloating, nausea, vomiting or early satiety. Persistent or recurrent symptoms occurring at least three times per week during six or more months in the year(s) preceding the study. Age 18 years and above. Written informed consent. H. pylori positive on rapid urease test. Previous treatment for H. pylori less than 4 weeks prior to endoscopy. Allergy to penicillins or macrolides. Significant liver or kidney disease. Severe cardiac or pulmonary disease. Suspected or confirmed malignancy. Concurrent reflux oesophagitis. Active upper gastrointestinal bleeding. History of gastric surgery except uncomplicated appendectomy, cholecystectomy or hernia repair. Pregnancy or breast-feeding. Patients using antibiotics in the month before inclusion, bismuth-containing compounds during the 3 months before inclusion, or Proton pump inhibitors, H2 receptor antagonists, misoprostol or sucralfate in the 2 weeks before the pre-entry endoscopy. Patients receiving regular treatment with Non-steroidal analgesics more than or equal to 5 days a week, for at least 2 weeks during the month before the start of the study. 18 Years 85 Years 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 2010/08/06 KEMRI/NATIONAL ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
P. O. Box 54840 nairobi 00200 Kenya

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Eradication of H. pylori infection At the end of trial
Secondary Outcome Prevalence of H. pylori infection in patients undergoing endoscopy At the end of trial
Secondary Outcome Efficacy of H. pylori drug regime At the end of trial

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Clinical Research, endoscopy unit, KEMRI P. O. Box 54840 Nairobi 00200 Kenya

FUNDING SOURCES
Name of source Street address City Postal code Country
Soraya P. Mavumba P. O. Box 67406 Nairobi 00200 Kenya

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Jomo Kenyatta University of Agricuture and Technology P. O. Box 62000 Thika Kenya University
Secondary Sponsor KEMRI P. O. Box 54840 Nairobi 00200 Kenya Hospital

COLLABORATORS
Name Street address City Postal code Country
Ciira Kiiyukia P. O. Box 62000 Thika Kenya
Moses Mwangi CPHR, P. O. Box 54840 Nairobi 00200 Kenya
Samuel Kariuki CMR, P. O. Box 54840 Nairobi 00200 Kenya
Dr. Hudson Lodenyo CCR, P. O. Box 54840 Nairobi 00200 Kenya

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Soraya Mavumba soraya_mav@yahoo.com +254722998757
Street address City Postal code Country Position / Affiliation
P. O. Box 67406 Nairobi 00200 Kenya ITROMID/JKUAT student
Role Name Email Phone Fax
Public Enquiries Dr Ciira Kiiyukia kiiyukia@yahoo.com +254722896536
Street address City Postal code Country Position / Affiliation
JKUAT, P. O. Box 62000, Thika Kenya Lecturer
Role Name Email Phone Fax
Scientific Enquiries Mr Samuel Kariuki samkariuki2@gmail.com +254722232467
Street address City Postal code Country Position / Affiliation
CMR,P. O. Box 54840 Nairobi 00200 Kenya CMR Director