Protocol summary

Summary
Objective: To evaluate the treatment of Helicobacter pylori eradication in peptic ulcer disease Two different treatment regimen with high dose furazolidone will be used to determine the effectiveness of any of these regimes and treatment regimen should be recommended. Methods:In this clinical trial, 170 patients with peptic ulcer admitted to the hospital martyr Sayyad Shirazi, an upper gastrointestinal endoscopy study with H. pylori infection were selected. None of the subjects in the study population history of smoking, alcohol and had previous treatment of Helicobacter pylori. In this study, 85 samples divided into two groups and treated with different doses of furazolidone were two drug regimen 4. Six weeks after completion of treatment of all samples analyzed in order to prove Helicobacter Pylori Eradication carbon-labeled urea breath test was performed. The patients in terms of response to treatment will be evaluated and the eradication of Helicobacter pylori.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011826084N1
Registration date: 2016-08-10, 1395/05/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-10, 1395/05/20
Registrant information
Name
Majid Rajabi
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 6240
Email address
m.rajabi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan Research Center of Gastroenterology and Hepatology
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the results of eradication of Helicobacter pylori in two different doses of furazolidone quadruple therapy in the treatment of patients with peptic ulcer
Public title
The effect of two different regimes furazolidone on Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: peptic ulcer with endoscopic diagnosis, proof of Helicobacter pylori infection by testing RUT; consenting to the partnership Exclusion criteria: pregnancy, the risk of cancer, liver failure and kidney disease, diabetes mellitus, history of taking NSAIDs; PPI; bismuth; anti- antibiotics during the past 4 weeks, history of smoking and alcohol; history of drug allergy.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 170
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 Blvd, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.GOUMS.REC.1394.135

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
ELISA Method

Secondary outcomes

1

Description
Peptic Ulcer cure
Timepoint
after intervention
Method of measurement
by Endoscopy

Intervention groups

1

Description
Group I: Quadruple Therapy (OfAB) with low-dose (amoxicillin mg-BD 1000, furazolidone mg-BD 100, omeprazole mg-BD20 Vbysmvt subcitrate mg-BD 240 for 2 weeks)
Category
Treatment - Drugs

2

Description
Group II: Quadruple therapy (OFAB) high dose (amoxicillin mg-BD 1000, furazolidone mg-BD 200, omeprazole mg-BD20 Vbysmvt subcitrate mg-BD 240 for 2 weeks)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sayyad Shirazi Hospital
Full name of responsible person
Dr Majid Rajabi
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blvd, 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 Mohammad Hossein Taziki
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blvd, 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 Majid Rajabi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blvd, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Phone
+98 17 3242 1660
Fax
Email
majid_rk5863@yahoo.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 Majid Rajabi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blvd, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Phone
+98 17 3242 1660
Fax
Email
majid_rk5863@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 Majid Rajabi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Sayyad Shirazi Hospital, Sayyad Shirazi Blvd, Gorgan, Golestan, Iran
City
Gorgan
Postal code
Phone
00
Fax
Email
majid_rk5863@yahoo.com
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
Loading...