Protocol summary

Summary
This study is a clinical trial which aims to compare the efficacy and adverse effects of seven and ten-day quadruple regimen in the treatment of patients with H. pylori referred to the gastroenterology and liver Clinic in Rasht. H. Pylori infection is confirmed according to carbon-13 or 14-UBT, pathology or stool antigen. Demographic data, smoking and commodities recorded for all patients. Then patients are randomly divided into two groups. The first group is treated with four drugs (bismuth sub citrate, levofloxacin, amoxicillin, pantozol) for seven days. The second group received the same formula for a period of ten days. Complications are recorded for both groups 2 weeks after treatment. Eight weeks after the treatment, Urea Breath Test (with carbon 14) is done for patients to determine resistance or eradication of infection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201406141155N19
Registration date: 2015-07-10, 1394/04/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-10, 1394/04/19
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2015-07-15, 1394/04/24
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between effects and side effects of seven days or ten days quadruple therapy regimens (Bismuth sub citrate, Levofloxacin, Amoxicillin and Pantazole) in eradication of H.pylori infection.
Public title
Compare seven and ten days quadruple regimen for H. pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: H. pylori infection has been confirmed in accordance with Urea Breath Test with carbon-13 or 14 or pathology or stool antigen, The patient satisfaction Exclusion criteria: Pregnant and lactating women, Patients with esophageal cancer, Liver cirrhosis, Heart failure; kidney failure, History of seizures, Hematologic diseases; Allergy to drugs, Patients with an incomplete course of treatment; Severe complications; Discontent to treatment
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 220
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
Ethics Committee Guilan University of Medical Sciences .
Street address
Namjoo Ave
City
Rasht
Postal code
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
1930175713

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified to other chapters

Primary outcomes

1

Description
Eradication of infection
Timepoint
Eight weeks after completion of treatment
Method of measurement
Urea breath test (Carbon 14)

Secondary outcomes

1

Description
Complications
Timepoint
Two weeks after completion of treatment
Method of measurement
According to the case history

Intervention groups

1

Description
Administration of quadruple therapy for seven days as follows: Bismuth sub citrate (Chemidarou company) 240 mg BID, Levofloxacin (Abidi company) 500 mg daily, Amoxicillin (Chemidarou company) 1 g BID, Pantozol (Nokomed company) 20 mg BID
Category
Treatment - Drugs

2

Description
Administration of quadruple therapy for ten days as follows: Bismuth sub citrate (Chemidarou company) 240 mg BID, Levofloxacin (Abidi company) 500 mg daily, Amoxicillin (Chemidarou company) 1 g BID, Pantozol (Nokomed company) 20 mg BID
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center, Guilan
Full name of responsible person
Dr. Mansour Ghanaei Fariborz
Street address
Gastrointestinal and Liver Diseases Research Center, Razi hospital, Sardar jangle Ave
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vince Chancellor for Research Guilan University of Medical Sciences .
Full name of responsible person
Dr. Tabari Khomeirani Rasool
Street address
Sadati St, Namjoo Ave
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vince Chancellor for Research Guilan 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
Guilan Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Joukar Farahnaz
Position
Assistant in Guilan Gastrointestinal and Liver Diseases Research Center
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center, Razi hospital, Sardar jangle Ave
City
Rasht
Postal code
955655-41448
Phone
+98 13 3353 5116
Fax
Email
info @gldrc.org
Web page address
www.gldrc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Mansour Ghanaei Fariborz
Position
professor
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center, Razi hospital, Sardar jangle Ave
City
Rasht
Postal code
Phone
+98 13 3353 5116
Fax
Email
info @gldrc.org
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Guilan Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Masihypour Behnam
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Razi hospital, Sardar jangle Ave
City
Rasht
Postal code
955655-41448
Phone
+98 13 3353 5116
Fax
Email
Dr.bmasihypour@yahoo.com
Web page address
www.gldrc.org

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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