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Completed

NCT Number: NCT02711176

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ilam University of Medical Scienvc

Īlām, 6939177143, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexium

Drug

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

Other names: Esomeprazole

Tinafas

Drug

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

Other names: Tinidazole

Tavanex

Drug

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

Other names: Levofluxacine

Lanzol

Drug

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

Other names: lansoprazole

Klacid

Drug

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

Other names: clarithromycin

Iramox

Drug

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

Other names: amoxicillin

Primary outcomes

  1. The rate of H.pylori eradication

    Time frame: 42 days after study completion

    Breath Urea Test

Secondary outcomes

  1. Drug Compliance

    Time frame: within the first week after study completion

    Interview

Sponsors and collaborators

Lead sponsor

Zahra Vahdat Shariatpanahi

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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