Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection

June 7, 2017 updated by: Zahra Vahdat Shariatpanahi
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tavanex & Nexium & Tinafas
Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"
Drug: Nexium
Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily
Other Names:
  • Esomeprazole
Drug: Tinafas
Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily
Other Names:
  • Tinidazole
Drug: Tavanex
Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily
Other Names:
  • Levofluxacine
Active Comparator: Lanzol & Klacid &Iramox
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
Drug: Lanzol
Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily
Other Names:
  • lansoprazole
Drug: Klacid
Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily
Other Names:
  • clarithromycin
Drug: Iramox
Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily
Other Names:
  • amoxicillin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of H.pylori eradication
Time Frame: 42 days after study completion
Breath Urea Test
42 days after study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Compliance
Time Frame: within the first week after study completion
Interview
within the first week after study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zahra Vahdat Shariatpanahi

Investigators

  • Principal Investigator: Shaahin Shahbazi, MD, Assistant Professor, Ilam University of Medical Sciences,Head of Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

March 27, 2017

Study Completion (Actual)

March 27, 2017

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

March 12, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/52/1662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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