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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-27

Brief Summary

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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.

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Detailed Description

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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

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Helicobacter Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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"

Group Type EXPERIMENTAL

Nexium

Intervention Type DRUG

Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily

Tinafas

Intervention Type DRUG

Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily

Tavanex

Intervention Type DRUG

Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily

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

Group Type ACTIVE_COMPARATOR

Lanzol

Intervention Type DRUG

Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily

Klacid

Intervention Type DRUG

Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily

Iramox

Intervention Type DRUG

Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily

Interventions

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Nexium

Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily

Intervention Type DRUG

Tinafas

Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily

Intervention Type DRUG

Tavanex

Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily

Intervention Type DRUG

Lanzol

Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily

Intervention Type DRUG

Klacid

Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily

Intervention Type DRUG

Iramox

Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily

Intervention Type DRUG

Other Intervention Names

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Esomeprazole Tinidazole Levofluxacine lansoprazole clarithromycin amoxicillin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No