Helicobacter Pylori Infection | Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections
Helicobacter Pylori Infection research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Helicobacter Pylori Infection
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:RA5-RACM7rabeprazole 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
Drug:RA3-RACM7rabeprazole 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
Drug:RA7-RACM7rabeprazole 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
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.
Hybrid-10RA3-RACM7: rabeprazole + amoxicillin x 3 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days.
Hybrid-12RA5-RACM7: rabeprazole + amoxicillin x 5 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days
Hybrid-14RA7-RACM7: rabeprazole + amoxicillin x 7 days, then rabeprazole + amoxicillin + clarithromycin + metronidazole x 7 days
Start Date: January 2011
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: Eradication rate
Study sponsors, principal investigator, and references
Principal Investigator: Ming-Cheh CHEN, MD
Lead Sponsor: Buddhist Tzu Chi General Hospital
Collaborator: Kaohsiung Medical University