The aim of this study is to evaluate Sequential therapy versus the best quadruple drug therapy for helicobacter pylori eradication. 296 patients with duodenal ulcer in whom H.pylori infection has been documented by rapid urease test will be enrolled in the study. The patients will be randomly received one of following interventions: 1) Pantoprazole 40mg (BD) + Amoxicillin 1g (BD) + Bismuth 240mg (BD) for 2 weeks and Furazolidone 200mg (BD) just during the first week 2) Pantoprazole 40mg (BD) for 10 days + Amoxicillin 1g (BD) just during the first 5 days + Clarithromycin 500mg (BD) and Tinidazole 500mg (BD) just during the second 5 days. Patients will be visited after the treatment course to be asked about their compliance to treatment and side effects. H pylori eradication will be tested at least 8 weeks after the treatment course using C14-UBT.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807022499N1
Registration date:2010-02-06, 1388/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-02-06, 1388/11/17
Registrant information
Name
Hafez Tirgar Fakheri
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
hfakheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research - Mazandaran University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sequential therapy versus the best quadriple drug therapy for helicobacter pylori eradication
Public title
Sequential therapy versus the best quadriple drug therapy for helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years
Exclusion criteria: Previous history of receiving any H.p eradication regimen, Taking H2 blocker, proton pump inhibitor, Bismuth or Antibiotics during the 2 weeks prior to the study, Taking anticoagulants, ketoconazole or corticosteroids, History of gastric or esophageal surgery, Severe cardiovascular, pulmonary or endocrine disease, Renal failure, Hepatic diseases, Malignancies, Alcoholism, G6PD deficiency, Pregnancy or breast feeding
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
296
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Sari
City
Sari
Postal code
Approval date
2008-11-20, 1387/08/30
Ethics committee reference number
87-82
Health conditions studied
1
Description of health condition studied
Peptic Ulcer Disease (H. Pylori eradication)
ICD-10 code
K26
ICD-10 code description
Duodenal ulcer
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
2 months after the completion of treatment course
Method of measurement
urease breating test
Secondary outcomes
1
Description
Side effects of drugs
Timepoint
daily recording during and after the treatmen course
Method of measurement
classifying as mild, moderate or severe side effects
Intervention groups
1
Description
Intervention group: Pantoprazole 40mg (BD) for 10 days + Amoxicillin 1g (BD) just during the first 5 days + Clarithromycin 500mg (BD) and Tinidazole 500mg (BD) just during the second 5 days
Category
Treatment - Drugs
2
Description
Control group: Pantoprazole 40mg (BD) + Amoxicillin 1g (BD) + Bismuth 240mg (BD) for 2 weeks and Furazolidone 200mg (BD) just during the first week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Hafez Fakheri
Street address
Imam Khomeini Hospital, Sari, Razi street
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyed Jalal Hosseinimehr
Street address
Vice Chancellor For Research, Mazandaran University of Medical Sciences, Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Hafez Tirgar Fakheri
Position
Associate Professor
Other areas of specialty/work
Street address
Internal Medicine Department, Imam Khomeini Hospital, Razi street, Sari
City
Sari
Postal code
48166-33131
Phone
+98 15 1226 1700
Fax
+98 15 1226 4044
Email
Hfakheri@mazums.ac.irfakheri42@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Hafez Tirgar Fakheri
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Razi street, Sari
City
Sari
Postal code
48166-33131
Phone
+98 15 1226 1700
Fax
+98 15 1226 4044
Email
Hfakheri@mazums.ac.irfakher42@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Hafez Tirgar Fakheri
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Razi Street, Sari-
City
Sari
Postal code
48166-33131
Phone
+98 15 1226 1700
Fax
+98 15 1226 4044
Email
Hfakheri@mazums.ac.irfakheri42@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)