Helicobacter pylori (H. pylori) colonizes not only on the surface of mucous membrane but also beneath the surface mucous gel layer (SMGL). As Na--diclofenac decreases the secretion of SMGL, in this study we examined this drug as an adjuvant therapy to a quadruple therapy for H. Pylori eradication. One hundred and seventy-two patients were randomly assigned to three groups. Fifty four patients received azithromycine 250 mg ,amoxicillin 500 mg, bismuth subcitrate 240 mg and omeprazole 20 mg) twice a day for 1 week (group A) and 65 patients received the same dosage of those agents plus Na -diclofenac tab, 100 mg daily for 1 week (group B). Sixty two patients received the same quadruple therapy for 2 weeks (group C), Eradication of the infection will assess four to six weeks after completion of treatment by stool antigen assay for H. pylori and finaly 8-10 weeks after treatment symtoms improvement will evalute by glasgow dyspepsia severity questionnare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204059256N2
Registration date:2012-05-13, 1391/02/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-13, 1391/02/24
Registrant information
Name
Ali Toghiani
Name of organization / entity
Islamic Azad University, Najafabad Branch, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 939 532 8865
Email address
toghiani@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciencies
Expected recruitment start date
2010-04-01, 1389/01/12
Expected recruitment end date
2011-04-01, 1390/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) in shortening the Helicobacterpylori eradication period
Public title
Effect of NSAIDs in H.pylori treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with H.pylori infection. Exclusion criteria: previous treatment for H. pylori infection; use of PPI (proton pomp inhibitors) during 2 weeks and/or antibiotics during 4 weeks before the study; having peptic ulcer, GERD, gastrointestinal malignancy, previous gastro-oesophageal surgery; severe concomitant cardiovascular, hypertention, respiratory or endocrine diseases, clinically significant renal or hepatic disease, haematological disorders; any other clinically significant medical conditions that could increase risk; history of allergy to any of the drug used in the study; pregnancy or lactation; alcohol abuse; drug addiction; severe neurological or psychiatric disorders and contraindication of consumption of NSAID and long-term use of corticosteroids or anti-inflammatory drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
172
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethics Committee
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2010-03-14, 1388/12/23
Ethics committee reference number
388565
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified
Primary outcomes
1
Description
helicobacter pylori eradication
Timepoint
4-6 weeks after completion of treatment
Method of measurement
stool antigen assay for H. pylori.
Secondary outcomes
1
Description
symptoms improvement
Timepoint
8-10 weeks after treatment
Method of measurement
glasgow dyspepsia severity questionnaire
Intervention groups
1
Description
Fifty four patients received quadruple therapy i.e. azithromycine 250 mg, amoxicillin 500 mg, bismuth subcitrate 240 mg and omeprazole 20 mg bid for 1 week (group A)
Category
Treatment - Drugs
2
Description
Sixty five patients received quadruple therapy i.e. azithromycine 250 mg, amoxicillin 500 mg, bismuth subcitrate 240 mg and omeprazole 20 mg bid plus diclofenac Na tab, 100 mg daily for 1 week (group B).
Category
Treatment - Drugs
3
Description
Sixty two received quadruple therapy i.e. azithromycine 250 mg, amoxicillin 500 mg, bismuth subcitrate 240 mg and omeprazole 20 mg bid plus diclofenac Na tab, 100 mg daily for 2 weeks (group C)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice chancellor for research and technology
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Akbar Arjmandpour
Position
MD
Other areas of specialty/work
Street address
Hezar jarib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 913 310 6394
Fax
Email
arjmandakbar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohamad Hassan Emami
Position
Associate Professor of gastroentrology
Other areas of specialty/work
Street address
Hezar jarib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1668 1429
Fax
Email
mh_emami@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Akbar Arjmandpour
Position
MD
Other areas of specialty/work
Street address
Hezar jarib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
Fax
Email
arjmandakbar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)