The objective of this study was to compare efficacy of standard triple therapy containing Clarithromycin with triple therapy containing Azithromycin in H pylori eradication. 150 patients were allocated in two groups to receive either a ten-day course of Clarithromycin 500 mg, Amoxicillin 1 gr, Omeprazole 20 mg, all twice daily or Azithromycin (250 mg bid in the first 4 days and then 250 mg daily), Amoxicillin 500 mg, and Omeprazole 20 mg both twice a day. Then all patients received thirty days of Famotidin. After treatment period urease breath test was done for all patients who have completed the course. Response to treatment and possible side effects are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809052777N1
Registration date:2010-01-13, 1388/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-01-13, 1388/10/23
Registrant information
Name
Seyed Saeid Sarkeshikian
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1291 9365
Email address
s-sarkeshikian@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2008-12-14, 1387/09/24
Expected recruitment end date
2009-12-14, 1388/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of Azithromycin and Clarithromycin in H pylori eradication
Public title
comparison of Azithromycin and Clarithromycin in H pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: H pylori positive patients with endoscopically documented peptic ulcer disease, presence of erosive gastritis or duodenitis or patients with normal endoscopy but first degree relative with gastric cancer
Exclusion criteria: age less than eighteen years old, gastric outlet obstructionT, history of allergy to penicillin derivatives
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Qom Medical University
Street address
Qom Medical University, Saheli street
City
Qom
Postal code
Approval date
2006-08-17, 1385/05/26
Ethics committee reference number
پ /34/25571
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
eradication of helicobacter pylori infection
Timepoint
after termination of 40 days course of treatment
Method of measurement
urease breath test
Secondary outcomes
empty
Intervention groups
1
Description
Azithromycin 250 mg/ bid /orally for 4 days and 250 mg/ daily/oral for additional 6 days, Amoxicillin 1 gr/bid/orally, Omeprazole 20 mg/bid/orally before meal both for 10 days
Category
Treatment - Drugs
2
Description
Clarithromycin 500 mg/bid/orally, Amoxicillin 1 gr/bid/orally and Omeprazole 20 mg/bid/orally before meal, for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gasterointestinal clinics of Qom University of Medical Sciences
Full name of responsible person
Seyed Saeid Sarkeshikian
Street address
no.31, 8th Alley, Jomhoori Boulvard,
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Division of Qom University of Medical Sciences
Full name of responsible person
Darabi
Street address
Saheli street,Qom Medical University
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Division of Qom 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
Qom University of Medical Sciences
Full name of responsible person
Seyed Saeid Sarkeshikian
Position
Assotiate professor/gasteroenterologist
Other areas of specialty/work
Street address
No. 31, 8th alley, Jomhoori Blvd
City
Qom
Postal code
3716687361
Phone
+98 25 1291 9365
Fax
+98 25 1292 0478
Email
s-sarkeshikian@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom Medical University
Full name of responsible person
Seyed Saeid Sarkeshikian
Position
Assotiate professor/gasteroenterologist
Other areas of specialty/work
Street address
No. 31, 8th alley, Jomhoori Blvd
City
Qom
Postal code
3716687361
Phone
+98 25 1291 9365
Fax
+98 25 1292 0478
Email
s-sarkeshikian@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Seyed Saeid Sarkeshikian
Position
Assotiate proffessor/Gastroenterologist
Other areas of specialty/work
Street address
Jomhoori Boulvard, Jomhoori 8,no: 31
City
Qom
Postal code
Phone
+98 25 1291 9365
Fax
Email
s-sarkeshikian@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)