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.: PACTR201211000440194 Date of Approval:
Trial Status:
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 Helicobacter pylori gastritis,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Helicobacter pylori gastritis
Purpose of the trial Treatment: Other
Anticipated trial start date 03/12/2007
Actual trial start date 03/12/2007
Anticipated date of last follow up 04/12/2009
Actual Last follow-up date 18/12/2009
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants) 150
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Participants
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 Age Category Minimum age Maximum 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 Year(s) 85 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 06/08/2010 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 KEMRI P. O. Box 54840 Nairobi 00200 Kenya Hospital
Secondary Sponsor Jomo Kenyatta University of Agricuture and Technology P. O. Box 62000 Thika Kenya University
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 Street address
Principal Investigator Soraya Mavumba soraya_mav@yahoo.com +254722998757 P. O. Box 67406
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya ITROMID/JKUAT student
Role Name Email Phone Street address
Public Enquiries Ciira Kiiyukia kiiyukia@yahoo.com +254722896536 JKUAT, P. O. Box 62000,
City Postal code Country Position/Affiliation
Thika Kenya Lecturer
Role Name Email Phone Street address
Scientific Enquiries Samuel Kariuki samkariuki2@gmail.com +254722232467 CMR,P. O. Box 54840
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya CMR Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information