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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02711176

Enrollment

212

Registered

2016-03-17

Start date

2016-09-30

Completion date

2017-03-27

Last updated

2017-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Infection

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.

Interventions

DRUGNexium

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

DRUGTinafas

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

DRUGTavanex

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

DRUGLanzol

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

DRUGKlacid

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

DRUGIramox

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Drug Compliance	within the first week after study completion	Interview

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026