Comparison of Levofloxacin- containing and Clarithromycin -containing Sequential Therapies for Helicobacter pylori Eradication in Iran: A Randomized Clinical Trial
This randomized clinical trial will be done on 182 patients at gastrointestinal clinic of Rasoul Akram Hospital, whose duodenal ulcer, gastric ulcer and/or erosions is diagnosed by endoscopy and H.pylori infection is detected by rapid urease test or histological Geimsa staining on biopsied specimens during endoscopy
The patients arerandomly enrolled to either of the two groups using a computer-generated randomization:
91 patients receive ( group A): esomeprazole (40 mg/b.i.d.) and amoxicillin (1000 mg/b.i.d.) for first 5 days and esomeprazole (40 mg/b.i.d.) and tinidazole and clarithromycin (each 500 mg/b.i.d.) for second 5 days.
91 patients receive(group B): esomeprazole (40 mg/b.i.d.) and amoxicillin (1000 mg/b.i.d.) for first 5 days and esomeprazole (40 mg/b.i.d.) and tinidazole and levofloxacin (each 500 mg/b.i.d.) for second 5 days. Patients record side effects of
medications(such as;Bitter taste,drymouth,diarrhea,constipation,headache,nausea,vomiting , and abdominal pain) on a daily basis and are advised to call the doctors if side effects are severe.All patients are visited 2 weeks after treatment.
They are also asked about drug side effects and their compliance to medication according to remaining pill count at the end of the treatment.Then ,they will be advised for 4 weeks consumption of PPI and for the last 4 weeks without any PPI and/ or antibiotics consumption . Ten weeks after starting the treatment, H. pylori eradication is assessed by 14C-urea breath test (UBT) . Treatment efficacy in each group is determined according to the Intention-To-Treat (ITT) and Per-Protocol (PP) eradication rates analysis. Chi square test is used for comparing proportion between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030820178N2
Registration date:2015-03-26, 1394/01/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Marjan Mokhtare
Name of organization / entity
Iran University of Medical sciences,Rasoul Akram Hospital,Colorectal Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 2845
Email address
mokhtare.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Iran University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Levofloxacin- containing and Clarithromycin -containing Sequential Therapies for Helicobacter pylori Eradication in Iran: A Randomized Clinical Trial
Public title
Efficacy of Levofloxacin- containing versus Clarithromycin -containing Sequential Therapies in Helicobacter pylori Eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age more than18 years,patients with endoscopically confirmed peptic ulcer or gastric/duodenal erosions and H. pylori infection documentation by antral biopsy (Giemsa staining) and/or rapid urease test (RUT). exclusion criteria:pregnancy, breast-feeding, previous history of helicobacter pylori eradication,significant underlying diseases such as liver, cardiac, pulmonary or renal diseases, neoplasms, coagulopathy, history of gastric surgery, taking antibiotics,proton pump inhibior and /or histamin2 receptor antagonist during the previous2 weeks,concomitant use ofanticoagulant and/or corticosteroid, and previous
history of allergic reaction to any medications used in
this study.
Age
From 18 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
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of Medical Sciences,West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori,Tehran Iran
City
Tehran
Postal code
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
105/5840/د/93
Health conditions studied
1
Description of health condition studied
gastric ulcer or erosion-deudenal ulcer or erosion
ICD-10 code
k25-K26 -B
ICD-10 code description
Gastric ulcer-Duodenal ulcer- Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Helicobacter pylori eradication rate
Timepoint
Ten weeks after starting treatment
Method of measurement
urea breath test(UBT)
Secondary outcomes
1
Description
Drug adverse effect rate
Timepoint
Two weeks after starting treatment
Method of measurement
Data gathering sheet
2
Description
Patient compliance rate
Timepoint
Two weeks after starting treatment
Method of measurement
Remained pill count
Intervention groups
1
Description
Group A:10 days of sequential therapy (esomeprazole 40 mg twice daily, amoxicillin 1g
twice daily for 5 days followed by esomeprazole 40 mg twice daily, levofloxacin 500 mg twice daily, and tinidazole 500 mg twice daily for 5 more days
Category
Treatment - Drugs
2
Description
Group B:10 days of sequential therapy (esomeprazole 40 mg twice daily, amoxicillin 1g
twice daily for 5 days followed by esomeprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and tinidazole 500 mg twice daily for 5 more days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasaul Akram Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center
Full name of responsible person
Shahram Agah
Street address
Sattarkhan Street, Niayesh Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center
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
Rasaul Akram Hospital
Full name of responsible person
Mehdi Nikkhah
Position
Fellow of Gastroenterology and hepatology
Other areas of specialty/work
Street address
Sattarkhan Street, Niayesh Street
City
Tehran
Postal code
Phone
+98 21 6655 4790
Fax
Email
nikkhahmd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal Research Center, Rasoul Akram Hospital
Full name of responsible person
Marjan Mokhtare
Position
Gastroenterologist and Hepatologist, Assistant professor
Other areas of specialty/work
Street address
Colorectal Research Center, Rasoul Akram Hospital,Niayesh Street,Sattarkhan Street