Text Size
Trial record 16 of 42 for:    "antibiotic resistance" | Open Studies
Previous Study | Return to List | Next Study

Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections

This study is currently recruiting participants.
Verified April 2012 by Buddhist Tzu Chi General Hospital
Sponsor:
Collaborator:
Kaohsiung Medical University
Information provided by (Responsible Party):
Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01566643
First received: March 27, 2012
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

This prospective controlled randomized open-label clinical trial is designed to determine the optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3, 5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin, then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin + metronidazole.


Condition Intervention Phase
Helicobacter Pylori Infection
 Drug: RA5-RACM7
Drug: RA3-RACM7
Drug: RA7-RACM7
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • Eradication rate [ Time Frame: 4 weeks after complete use of drug for treatment ] [ Designated as safety issue: No ]
    A negative post-treatment 13C-urea breath test result at more than 4 weeks after complete use of drug for treatment.


Estimated Enrollment: 231
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hybrid-10
RA3-RACM7: rabeprazole + amoxicillin x 3 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days.
 Drug: RA3-RACM7
rabeprazole 20mg bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days
Other Names:
  • Pariet x 10 days.
  • Hiconcil x 10 days.
  • Klarid x 7 days.
  • Flagyl x 7 days.
Experimental: Hybrid-12
RA5-RACM7: rabeprazole + amoxicillin x 5 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days
 Drug: RA5-RACM7
rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days
Other Names:
  • Pariet x 12 days.
  • Hiconcil x 12 days.
  • Klarid x 7 days.
  • Flagyl x 7 days.
Experimental: Hybrid-14
RA7-RACM7: rabeprazole + amoxicillin x 7 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days
 Drug: RA7-RACM7
rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days
Other Names:
  • Pariet x 14 days.
  • Hiconcil x 14 days.
  • Klarid x 7 days.
  • Flagyl x 7 days.

Detailed Description:

Background: Antimicrobial resistance has decreased the worldwide eradication rates of common used triple therapy for Helicobacter pylori infection (less than 80%).

Objective: To determine the optimal pre-concommitant treatment length for rabeprazole based sequential-concomitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan.

Design: Randomized, open-label, prospective controlled trial.

Patients: 231 patients with dyspepsia or peptic ulcers and infected by Helicobacter pylori.

Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.

Intervention: 231 patients with Helicobacter pylori infection are recruited and randomly assigned to receive one of the following therapeutic schemes: group 1, 14-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days; group 2, 12-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days; group 3, 10-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days. Repeat upper endoscopy for histologic evaluation, rapid urease test or 13C-urea breath test after 4 week of treatment to assess the treatment result. The influence on the hybrid therapies of antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host were determined.

Expected results: The rabeprazole based sequential-concomitant therapies for eradication of Helicobacter pylori is very effective, and the outcome is not affected by antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient proved with infection of H. pylori in gastric mucosa (at least two of four tests positive)

Exclusion Criteria:

  • woman in breast feeding or pregnancy.
  • allergy to drugs used in study.
  • previously treated for H. pylori.
  • intolerance to fructose, lactose.
  • patients with hematologic, brain or spinal disorders
  • patients under 20 years old
  • patients under aspirin or clopidogrel
  • patients with history of gastric cancer or gastric resection operation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566643

Contacts
Contact: Ming-Cheh CHEN, MD +886-910-521003 MingCheh_chen@tzuchi.com.tw

Locations
Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien, Taiwan, 97002
Contact: Ming-Cheh CHEN, MD     +886-910-521003     MingCheh_chen@tzuchi.com.tw    
Principal Investigator: Ming-Cheh CHEN, MD            
Sub-Investigator: Chi-Tan HU, PhD, MD            
Sub-Investigator: Wei-Yi RAY, MD            
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Kaohsiung Medical University
Investigators
Principal Investigator: Ming-Cheh CHEN, MD Buddhist Tzu Chi General Hospital
  More Information

No publications provided

Responsible Party: Ming-Cheh Chen, Principal Investigator, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01566643     History of Changes
Other Study ID Numbers: TCRD100-16, IRB099-71
Study First Received: March 27, 2012
Last Updated: April 4, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Buddhist Tzu Chi General Hospital:
Helicobacter pylori
antibiotic resistance
sequential-concomitant hybrid therapy

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Metronidazole
Rabeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013