Sequential & Hybrid Therapies for H Pylori Infection

Status Completed

Clinical Trial Summary

Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.

Clinical Trial Description

The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.

A total of 240 subjects will be asked to participate in this study.

H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).

Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.

A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01085786
Study type	Interventional
Source	Kaohsiung Veterans General Hospital.
Contact
Status	Completed
Phase	Phase 4
Start date	August 2008
Completion date	May 2010

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05061732` - Helicobacter Pylori Eradication and Follow-up	Phase 4
Completed	`NCT03779074` - Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies	Phase 3
Completed	`NCT06076681` - A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules	Phase 1/Phase 2
Recruiting	`NCT05329636` - Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy	Phase 1/Phase 2
Recruiting	`NCT05065138` - Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists	N/A
Completed	`NCT05049902` - Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication	Phase 4
Not yet recruiting	`NCT06200779` - Tailored vs. Empirical Helicobacter Pylori Infection Treatment	Phase 4
Not yet recruiting	`NCT06037122` - Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
Completed	`NCT04617613` - Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait	Phase 4
Completed	`NCT02873247` - Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
Withdrawn	`NCT02552641` - Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole	Phase 4
Completed	`NCT02557932` - Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication	Phase 3
Recruiting	`NCT02249546` - Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection	Phase 4
Completed	`NCT01933659` - Anti-H. Pylori Effect of Deep See Water	Phase 3
Unknown status	`NCT01464060` - 14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication	Phase 4
Completed	`NCT00841490` - Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults	N/A
Recruiting	`NCT05549115` - Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection	N/A
Recruiting	`NCT05728424` - One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL	Phase 3
Recruiting	`NCT05997433` - Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)	N/A
Completed	`NCT04708405` - The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sequential and Hybrid Therapies for H Pylori Infection

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms