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Comparision of two quadriple regimen amoxicillin, bismuth subsalicylate, pantoprazole, clarythromycin and amoxicillin, bismuth subsalicylate, pantoprazole, gemifloxacin in eradication of H.pylori infection

Protocol summary

Summary
Comparision of two quadriple regimen amoxicillin, bismuth subsalicylate, pantoprazole, clarythromycin and amoxicillin, bismuth subsalicylate, pantoprazole, gemifloxacin in eradication of H.pylori infection. This study is a randomized clinical trial in new patients with H.pylori infection. Inclusion criteria: New cases of H.pylori infection; patients between 18 to 80 years old Exclusion criteria: The pregnant and brest feeding women; gastric and esophagial malignancies; pylor stenosis; iiver cirrhosis; opium addicts; hypersensitivity to amoxicillin; bismuth subsalicylate; pantoprazole; clarythromycin; gemifloxacin; using cholestyramine; renal failure; history of sizzure; favism and hematologic disorders; incomplete treatment (under 80%); consent to continue treatment; history of H.pylori treatment. One hundred eighty two patients divided to two groups. One group treated with cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab clarythromycin 500 miligram one number every 12 hours and the other group treated with cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab gemifloxacin 320 miligram one number daily for 10 days period. Eight to twelve weeks after completion of treatment, all of patients assessed about eradication of H.pylori infection through urease breath test (UBT) with 14 carbon. Finally, two groups are going to compare about succeeding in eradication of H.pylori infection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310221155N17
Registration date: 2014-09-03, 1393/06/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-03, 1393/06/12
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
Guilan University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of two quadriple regimen amoxicillin, bismuth subsalicylate, pantoprazole, clarythromycin and amoxicillin, bismuth subsalicylate, pantoprazole, gemifloxacin in eradication of H.pylori infection
Public title
The effect of gemifloxacin in treatment of H.pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: New cases of H.pylori infection; patients between 18 to 80 years old Exclusion criteria: The pregnant and brest feeding women; gastric and esophagial malignancies; pylor stenosis; iiver cirrhosis; opium addicts; hypersensitivity to amoxicillin; bismuth subsalicylate; pantoprazole; clarythromycin; gemifloxacin; using cholestyramine; renal failure; history of sizzure; favism and hematologic disorders; incomplete treatment (under 80%); consent to continue treatment; history of H.pylori 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: 182
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences. Ethics Committee of Gastrointestinal and Liver Diseases Resea
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
955655-41488
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
175-ش

Health conditions studied

1

Description of health condition studied
Dyspepsia
ICD-10 code
k30
ICD-10 code description
Dyspepsia

Primary outcomes

1

Description
Helicobacter pylori eradication
Timepoint
12 weeks
Method of measurement
Ureas Breath Test with C14

Secondary outcomes

1

Description
Comparision of two quadriple regimen amoxicillin, bismuth subsalicylate, pantoprazole, clarythromycin and amoxicillin, bismuth subsalicylate, pantoprazole, gemifloxacin in eradication of H.pylori infection
Timepoint
8-12 weeks
Method of measurement
UBT

Intervention groups

1

Description
Control group take cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab clarythromycin 500 miligram one number every 12 hours for 10 days period
Category
Treatment - Drugs

2

Description
Intervention group take cap amoxicillin 500 miligram two numbers every 12 hours, tab bismuth subsalicylate 120 miligram two numbers every 12 hours, tab pantoprazole 20 miligram one number daily, tab gemifloxacin 320 miligram one number daily for 10 days period
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Fariborz Mansour ghanei
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan Univercity of Medical Sciences
Full name of responsible person
Dr Rasool Tabari KHomeirani
Street address
Sadati st, Samjoo st, Rasht,Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan Univercity 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
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Farahnaz Joukar
Position
Gastrointestinal and Liver Diseases Research Center
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi hospital, Rasht
City
Rasht
Postal code
955655-41448
Phone
+98 13 1553 5116
Fax
Email
info@gldrc.org
Web page address
www.gldrc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Position
Full Professor of Internal Medicine & Gastroenterology
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
95655-41448
Phone
+98 13 1553 5116
Fax
Email
info@gldrc.org
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr. Zahra Pedarpour Vajargah
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Sardar Jangal Ave, Gastrointestinal and Liver Diseases Research Center, Razi Hospital, Rasht, Iran
City
Rasht
Postal code
Phone
00
Fax
Email
petunia.z2011@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
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