1. Home
  2. Approved trials
  3. » فارسی

Comparison of helicobacter pylori eradication rate with four different quadruple regimens in dyspeptic patients.

Protocol summary

Summary
Objectives: The aim of this study was to compare the eradication of Helicobacter pylori in dyspeptic patients is four quadruple regimen. Design and Methods: In this prospective, randomized, open-label study , 270 patients with positive rapid urease test were randomly divided into four treatment groups. Inclusion and exclusion criteria: Patients with positive rapid urease test that their chronic gastritis and Infection with Helicobacter pylori confirmed with histology were entered and Persons under 18 years of age at the time of endoscopy, those in the last month or bismuth compounds contain any antibiotics for any illness received., Pregnant and lactating women, people with serious diseases such as congestive heart failure, end-stage renal failure , cirrhosis and psychosis, patients with active gastrointestinal bleeding (upper), previous use of H. pylori eradication regimen and any favism patients were excluded from the study. Interventions: Group A: Treatment with omeprazole + amoxicillin + clarithromycin + bismuth subcitrate for two weeks (73 patients) Group B: Treatment with omeprazole + tetracycline + bismuth subcitrate + metronidazole for two weeks (46 patients Group C: Treatment with omeprazole + amoxicillin + furazolidone + bismuth subcitrate for two weeks (64 patients Group D: The first week: omeprazole + amoxycillin + bismuth subcitrate + Furazolidone then the second week: omeprazole + amoxicillin + bismuth subcitrate + metronidazole (87 patients). The main outcome variables: Six weeks after stopping treatment, eradication rate, acceptance rate, and side effects were determined in each group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013010612024N1
Registration date: 2013-02-13, 1391/11/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-13, 1391/11/25
Registrant information
Name
Shahnaz Naghashi
Name of organization / entity
Liver and Gastrointestinal Diseases Research Center of Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 7473
Email address
naghashish@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of helicobacter pylori eradication rate with four different quadruple regimens in dyspeptic patients.
Public title
Comparison of helicobacter pylori eradication rate with four different quadruple regimens in dyspeptic patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with positive rapid urea’s test that confirmed with histological finding of helicobacter pylori infection and chronic gastritis were entered in study. Persons under 18 years of age at the time of endoscopy; those in the last month or bismuth compounds contain any antibiotics for any illness received; Pregnant and lactating women; people with serious diseases such as congestive heart failure; end-stage renal failure; cirrhosis and psychosis; patients with active gastrointestinal bleeding (upper); previous use of H. pylori eradication regimen and any favism patients were excluded from the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 270
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Medical Sciences Vice for research,Third floor,Central Building Number 2,Tabriz University of Medical Sciences ,Gholghasht st,Tabriz
City
Tabriz
Postal code
5165118
Approval date
2008-07-21, 1387/04/31
Ethics committee reference number
5/4/5656

Health conditions studied

1

Description of health condition studied
Infection with Helicobacter pylori
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 Helicobacter pylori
Timepoint
6 weeks after end of treatment
Method of measurement
UBT

Secondary outcomes

1

Description
Side effects of treatment
Timepoint
At the time of treatment
Method of measurement
Questionnaire

Intervention groups

1

Description
Group“A”: who received omeprazole 20mg / BID+amoxicillin1g/BID +bismuth subcitrate240 mg/ BID +clarithromycin 500mg / BID for 2 weeks (73 patients)
Category
Treatment - Drugs

2

Description
Group B: Treatment with omeprazole 20mg / BID + tetracycline 500 mg/ QID+ bismuth subcitrate 240 mg/BID + metronidazole 250 mg/ QID for two weeks (46 patients)
Category
Treatment - Drugs

3

Description
Group C: Treatment with omeprazole 20mg / BID + amoxicillin1g/ BID + furazolidone 200mg/BID + bismuth subcitrate 240 mg/ BID for two weeks (64 patients)
Category
Treatment - Drugs

4

Description
Group D: The first week : omeprazole 20mg / BID + amoxycillin 1g/ BID + bismuth subcitrate 240mg/BID + Furazolidone200 mg/ BID then the second week: omeprazole 20mg / BID + amoxicillin 1g/ BID + bismuth subcitrate 240mg/BID+ metronidazole 250 mg/QID (87 patients).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital endoscopy
Full name of responsible person
Fattahi Ebrahim
Street address
Gastrointestinal and Liver Disease Research Center, Tabriz University of Medical Sciences,Imam Reza Hospital,Ghlghast avey , Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mirinezhad Seyed Kazem
Street address
Medical Sciences Vice for research, Third floor, Central Building Number 2, University of Medical Sciences, Gholghast street, Azadi street, Tabriz
City
Tabriz
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, Tabriz 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
Liver and gastrointestinal diseases research center of Tabriz University of Medical Sciences
Full name of responsible person
Naghashi Shahnaz
Position
GP/Researcher
Other areas of specialty/work
Street address
Liver and gastrointestinal diseases research center ,Imam Reza hospital,Gholghalsht st
City
Tabriz
Postal code
5166614756
Phone
+98 41 1336 7473
Fax
+98 33 67499
Email
naghashish@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Liver and gastrointestinal diseases research center of Tabriz University of Medical Sciences
Full name of responsible person
Fattahi Ebrahim
Position
Internist,Professor, Department of Internal
Other areas of specialty/work
Street address
Liver and gastrointestinal diseases research center of Tabriz University of Medical Sciences ,Imam Reza hospital,Ghilghasht st,Tabriz
City
Tabriz
Postal code
5166614756
Phone
+98 41 1336 7473
Fax
+98 33 67499
Email
eattahie@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Liver and gastrointestinal diseases research center of Tabriz University of Medical Sciences
Full name of responsible person
Naghashi Shahnaz
Position
GP/Researcher
Other areas of specialty/work
Street address
Liver and gastrointestinal diseases research center of Tabriz University of Medical Sciences ,Imam Reza hospital,Gholghast st.Tabriz
City
Tabriz
Postal code
5166614756
Phone
+98 41 1336 7473
Fax
+98 33 67499
Email
naghashish@tbzmed.ac.irshahnaznaghashymd@gmail.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...