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hybrid therapy in H.pylori

Protocol summary

Summary
The aim of this study is to evaluate Sequential therapy versus hybrid therapy for helicobacter pylori eradication.Inclusion criteria: age more than 18 years and less than 80 years with duodenal or gastric ulcers; duodenal or gastric erosions and helicobacter pylori positivity. Exclusion criteria: Previous history of receiving any H.pylori 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, Pregnancy or breast feeding. 296 patients with PUD(peptic ulcer disease) in whom H.pylori infection has been documented by rapid urease test or pathology will be enrolled in the study. The patients will be randomly received one of following interventions: 1) Hybrid: [pantoprazole 40mg (BD) + Amoxicillin 1g (BD)] x2weeks + Clarithromycin 500mg (BD) and Tinidazole 500mg (BD) during secon dweek. 2) Sequential : Pantoprazole 40mg (BD) for 10 days + Amoxicillin 1g (BD) just during the first 5 days + Clarithromycin 500mg (BD) and Tinidazole 500mg (BD) both just during the second 5 days in control group. Patients will be visited after the treatment course to be asked about their compliance to treatment and side effects. H pylori eradication that is primary end poin will be tested at least 8 weeks after the treatment course using C14-UBT (14-carbon urea breath test).

General information

Acronym
sequential-concomitant (hybrid)
IRCT registration information
IRCT registration number: IRCT201110312499N2
Registration date: 2011-12-02, 1390/09/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-02, 1390/09/11
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
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
hybrid therapy in H.pylori
Public title
comparison of sequential-concomitant hybrid to sequential therapy in h.pylori eradication rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years and less than 80 years with duodenal or gastric ulcers; duodenal or gastric erosions and helicobacter pylori positivity. Exclusion criteria: Previous history of receiving any H.pylori 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, Pregnancy or breast feeding
Age
From 18 years old to 80 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
Imam Khomeini Hospital, Sari, Razi street Sari Mazandaran
City
sari
Postal code
Approval date
2011-08-07, 1390/05/16
Ethics committee reference number
90-107

Health conditions studied

1

Description of health condition studied
PUD(H.PYLORI ERADICATION REGIMEN)
ICD-10 code
K25.9,K26.
ICD-10 code description
GASTRIC ULCER,DUODENAL ULCER,PEPTIC ULCER DISEASE, GASRTRODUODENITIS

Primary outcomes

1

Description
Helicobacter pylori eradication rate
Timepoint
2 months after the completion of treatment course
Method of measurement
urease breath test

Secondary outcomes

1

Description
Side effects of drugs
Timepoint
daily recording during and after the treatment course
Method of measurement
classifying as mild, moderate or severe side effects

Intervention groups

1

Description
Intervention group: pantoprazole 40mg (BD) + Amoxicillin 1g (BD) + Clarithromycin 500mg (BD) and Tinidazole 500mg (BD) during the first 2 weeks
Category
Treatment - Drugs

2

Description
Control 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

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Hafez Fakheri
Street address
Imam Khomeini Teaching Hospital, Sari, Razi street Sari Mazandaran 33131-48166 00981512261700
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.Ahmadali Enayati
Street address
Vice Chancellor For Research, Mazandaran University of Medical Sciences, Sari Mazandaran Iran, Islamic Republic Of 00981513257230 00981513261244 Hfakheri@mazums.ac.ir fakher42@yahoo.com
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
Imam Khomeini Hospital, Razi street,Internal Medicine Department, Sari Mazandaran Iran, Islamic Republic Of 00981512261700 00989111521404 00981512264044
City
Sari
Postal code
Phone
00981512261700 00989111521404 00981512264044
Fax
Email
Hfakheri@mazums.ac.ir fakheri42@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, Internal Medicine Department, Sari ,Mazandaran
City
Sari
Postal code
Phone
00981512261700 00989111521404 00981512264044
Fax
Email
Hfakheri@mazums.ac.ir fakher42@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
4816633131
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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