Status:
COMPLETED
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Lead Sponsor:
Forest Laboratories
Conditions:
Helicobacter Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) i...
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signatur...
Eligibility Criteria
Inclusion
- Positive H. Pylori status;
- Presence of upper gastro-intestinal symptoms;
- Mental and legal ability to sign informed consent.
Exclusion
- Previous surgery of the GI tract;
- Clinically significant impairment of renal or hepatic function;
- Severe unstable cardiovascular, pulmonary or endocrine disease;
- Barrett's oesophagus or high-grade dysplasia;
- Dysphagia or vomiting as major symptoms.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00669955
Start Date
June 1 2008
End Date
August 1 2009
Last Update
March 16 2017
Active Locations (1)
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1
Dr. I. Orpen
Bath, United Kingdom