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

Sponsor

Zahra Vahdat Shariatpanahi (Other)

Overall Status

Completed

CT.gov ID

NCT02711176

Collaborator

(none)

212

Enrollment

Location

Arms

6.8

Duration (Months)

31.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Infection	Drug: Nexium Drug: Tinafas Drug: Tavanex Drug: Lanzol Drug: Klacid Drug: Iramox	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Mar 27, 2017

Actual Study Completion Date :

Mar 27, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The rate of H.pylori eradication [42 days after study completion]
Breath Urea Test

Secondary Outcome Measures

Drug Compliance [within the first week after study completion]
Interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
1. 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