Trial | NCT02711176  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    212
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.
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 Started
Sep 30
2016
Primary Completion
Mar 27
2017
Study Completion
Mar 27
2017
Last Update
Jun 08
2017

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

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

Tavanex & Nexium & Tinafas Experimental

Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days"

Lanzol & Klacid &Iramox Active Comparator

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

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
No Results Posted