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

NCT01265069 | Unknown Phase 4

• 1 other identifier: 201005064M
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in H. pylori eradication;
2. 2.to compare the patient adherence and adverse effects of these treatment regimens;
3. 3.to investigate factors that may influence H. pylori eradication by these treatment regimens.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; concomitant therapy; high dose dual therapy; antibiotic resistance

Outcome Measures

Primary Outcomes (1)

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

  The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.

  1.5 years

Secondary Outcomes (1)

• 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

  1.5 years

Study Arms (2)

high dose dual therapy

ACTIVE COMPARATOR

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

Drug: high dose dual therapy

concomitant therapy

EXPERIMENTAL

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

Drug: concomitant therapy

Interventions

high dose dual therapy DRUG

rabeprazole 20mg qid,amoxicillin 750mg qid for 14days

high dose dual therapy

concomitant therapy DRUG

rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days

concomitant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10043, Taiwan

RECRUITING

Study Officials

• Jyh-Chin Yang, M.D.Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyh-Chin Yang, M.D.Ph.D

CONTACT

886-2-23123456; jcyang47@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 22, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

TW (1)