NCT02711176

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Zahra Vahdat Shariatpanahi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Infection

Interventions

Type	Name	Description
DRUG	Nexium	Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily
DRUG	Tinafas	Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily
DRUG	Tavanex	Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily
DRUG	Lanzol	Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily
DRUG	Klacid	Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily
DRUG	Iramox	Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-03-27
• Completion: 2017-03-27
• First posted: 2016-03-17
• Last updated: 2017-06-08

Locations

1 site across 1 country: Iran