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Helicobacter Pylori Infection | Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy

Helicobacter Pylori Infection research study

What is the primary objective of this study?

Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy. The aims of this study are: 1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Who is eligible to participate?

Inclusion Criteria: - patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy. Exclusion Criteria: - pregnant or nursing woman - serious concomitant illness and malignant tumor of any kind - history of hypersensitivity to test drugs - serious bleeding during the course of this ulcer - previous gastric surgery - receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Helicobacter Pylori Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:high dose dual therapyrabeprazole 20mg qid,amoxicillin 750mg qid for 14days

Drug:concomitant therapyrabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

high dose dual therapyGroup A - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days)

concomitant therapyGroup B - concomitant therapy (rabeprazole 20 mg, amoxicillin 1000 mg, metronidazole 500 mg, clarithromycin 500 mg, bid for 10 days).

Study Status

Unknown status

Start Date: November 2010

Completed Date: December 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: to compare the efficacy of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy

Secondary Outcome: to compare the adverse effects and patient adherence of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy

Study sponsors, principal investigator, and references

Principal Investigator: Jyh-Chin Yang, M.D.Ph.D.

Lead Sponsor: National Taiwan University Hospital

Collaborator: National Science Council, Taiwan

More information:https://clinicaltrials.gov/show/NCT01265069

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