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

Helicobacter Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711176
• Other study ID #: 22/52/1662
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2016
• Last updated: June 7, 2017
• Start date: September 2016
• Est. completion date: March 27, 2017

Study information

• Verified date: June 2017
• Source: Ilam University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: March 27, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infection
• Helicobacter Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ilam University of Medical Scienvc	Ilam

Sponsors (1)

Lead Sponsor	Collaborator
Zahra Vahdat Shariatpanahi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of H.pylori eradication	Breath Urea Test	42 days after study completion
Secondary	Drug Compliance	Interview	within the first week after study completion