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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

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: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

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.

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

Study Status

Unknown status

Start Date: January 2011

Completed Date: December 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Eradication rate

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ming-Cheh CHEN, MD

Lead Sponsor: Buddhist Tzu Chi General Hospital

Collaborator: Kaohsiung Medical University

More information:https://clinicaltrials.gov/show/NCT01566643

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