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Comparison of two anti helicobacterpylori second-line regiments in patients with peptic ulcer disease after failure of first line triple drug regiment

Protocol summary

Summary
The aim of this study is to compare two second-line therapy for H. pylori eradication regimen in patients with peptic ulcer disease after failure of first-line triple therapy Sayyad Shirazi Hospital in Gorgan.Patients with peptic ulcers caused by Helicobacter pylori infection and resistance to first-line the three-drug regimen will be enrolled. Patients randomly will be assigned to one of two treatment groups: 1) OLA 2) OFAB. 6 weeks after the end of treatment, UBT breathe test will be done and eradication rates in the two groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015123025770N1
Registration date: 2016-07-07, 1395/04/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-07, 1395/04/17
Registrant information
Name
Laleh Abbasi
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 6627
Email address
dr.laleh.abbasi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gastroenterology Research Center of Golestan province
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two anti helicobacterpylori second-line regiments in patients with peptic ulcer disease after failure of first line triple drug regiment
Public title
Comparing second-line treatment regimens for H. pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with peptic ulcer confirmed by endoscopy;Perfect for first-line treatment;Resistance and non-response to first-line therapy for Helicobacter pylori eradication Exclusion criteria: lack of regular use of antibiotics because of severe side effects.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee Golestan University of Medical Sciences
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.GOUMS.REC.1394.40

Health conditions studied

1

Description of health condition studied
Peptic Ulcer
ICD-10 code
K27
ICD-10 code description
Gastroduodenal Ulcer NOS

Primary outcomes

1

Description
H.Pylori Eradication
Timepoint
After Intervention
Method of measurement
Percent

Secondary outcomes

1

Description
Peptic Ulcer cure
Timepoint
after intervention
Method of measurement
Percent

Intervention groups

1

Description
in OLA group : patients will be treated with : omeprazole 40 mg daily, levofloxacin 500 mg and amoxicillin 2 g for 2 weeks
Category
Treatment - Drugs

2

Description
in OFAB group patients will be treated with: omeprazole 40 mg, 480 mg bismuth subcitrate, furazolidone 400 mg and amoxicillin 2 g for 2 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital
Full name of responsible person
Dr Laleh Abbasi
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv, Gorgan, Golestan, Iran
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr Taziki
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv, Gorgan, Golestan, Iran
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Dr Laleh Abbasi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Phone
+98 17 3242 1660
Fax
Email
laleh.abbasi3@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Seyedmajidi
Position
Subspecialty of Gastrology
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Phone
+1 32229561
Fax
Email
mrsmajidi55@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr Laleh Abbasi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blv, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Phone
+98 17 3242 1660
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
empty
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