Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
Primary Purpose
Helicobacter Infection
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Nexium
Tinafas
Tavanex
Lanzol
Klacid
Iramox
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Infection
Eligibility Criteria
Inclusion Criteria:
The patients who proved H. pylori infection following three methods
- Positive rapid urease test
- Histologic evidence of H. pylori by modified Giemsa staining
- Positive stool Antigen Test
Exclusion Criteria:
- Patients who received eradication therapy for H. pylori infection, previously
- H. pylori eradication failure because of poor compliance
- The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
- Advanced gastric cancer or other malignancy
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- Other severe concurrent diseases
- Previous allergic reactions to the study drugs
- Pregnant or lactating women
Sites / Locations
- Ilam University of Medical Scienvc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tavanex & Nexium & Tinafas
Lanzol & Klacid &Iramox
Arm Description
Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
Outcomes
Primary Outcome Measures
The rate of H.pylori eradication
Breath Urea Test
Secondary Outcome Measures
Drug Compliance
Interview
Full Information
NCT ID
NCT02711176
First Posted
February 9, 2016
Last Updated
June 7, 2017
Sponsor
Zahra Vahdat Shariatpanahi
1. Study Identification
Unique Protocol Identification Number
NCT02711176
Brief Title
Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
Official Title
Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 27, 2017 (Actual)
Study Completion Date
March 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zahra Vahdat Shariatpanahi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
Detailed Description
Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.
The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tavanex & Nexium & Tinafas
Arm Type
Experimental
Arm Description
Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
Arm Title
Lanzol & Klacid &Iramox
Arm Type
Active Comparator
Arm Description
Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Nexium
Other Intervention Name(s)
Esomeprazole
Intervention Description
Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily
Intervention Type
Drug
Intervention Name(s)
Tinafas
Other Intervention Name(s)
Tinidazole
Intervention Description
Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily
Intervention Type
Drug
Intervention Name(s)
Tavanex
Other Intervention Name(s)
Levofluxacine
Intervention Description
Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily
Intervention Type
Drug
Intervention Name(s)
Lanzol
Other Intervention Name(s)
lansoprazole
Intervention Description
Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Klacid
Other Intervention Name(s)
clarithromycin
Intervention Description
Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily
Intervention Type
Drug
Intervention Name(s)
Iramox
Other Intervention Name(s)
amoxicillin
Intervention Description
Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily
Primary Outcome Measure Information:
Title
The rate of H.pylori eradication
Description
Breath Urea Test
Time Frame
42 days after study completion
Secondary Outcome Measure Information:
Title
Drug Compliance
Description
Interview
Time Frame
within the first week after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients who proved H. pylori infection following three methods
Positive rapid urease test
Histologic evidence of H. pylori by modified Giemsa staining
Positive stool Antigen Test
Exclusion Criteria:
Patients who received eradication therapy for H. pylori infection, previously
H. pylori eradication failure because of poor compliance
The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
Advanced gastric cancer or other malignancy
Abnormal liver function or liver cirrhosis
Abnormal renal function or chronic kidney disease
Other severe concurrent diseases
Previous allergic reactions to the study drugs
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaahin Shahbazi, MD
Organizational Affiliation
Assistant Professor, Ilam University of Medical Sciences,Head of Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ilam University of Medical Scienvc
City
Ilam
ZIP/Postal Code
6939177143
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30635887
Citation
Shahbazi S, Vahdat Shariatpanahi Z. Comparison between daily single-dose triple therapy and conventional triple therapy on patient compliance and Helicobacter pylori eradication: A randomized controlled trial. Indian J Gastroenterol. 2018 Nov;37(6):550-554. doi: 10.1007/s12664-018-0916-z. Epub 2019 Jan 12.
Results Reference
derived
Learn more about this trial
Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
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