Postmarketing Surveillance Study With MOBEC®
Overview
The aim of the study is to investigate – the indication for MOBEC in a dose of 15 mg per day – the treatments patients were receiving before switching to 15 mg MOBEC – how treatment with 15 mg is assessed compared with previous treatment – how effective and safe treatment with 15 mg MOBEC is considered
Full Title of Study: “COX-2 Postmarketing Surveillance Study With MOBEC® 15 mg Tablets”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: December 2001
Interventions
- Drug: MOBEC
Arms, Groups and Cohorts
- MOBEC
Clinical Trial Outcome Measures
Primary Measures
- Nature and incidence of adverse drug reactions (ADR)
- Time Frame: up to week 8
- Assessment of efficacy by physician on a 5-point scale
- Time Frame: up to week 8
- Assessment of tolerability by physician on a 5-point scale
- Time Frame: up to week 8
Participating in This Clinical Trial
Inclusion Criteria
- An indication for a treatment with 15 mg MOBEC of at least four weeks – the symptomatic short-term treatment of osteoarthritis – the symptomatic long-term treatment of rheumatoid arthritis (chronic polyarthritis); restriction: the recommended dose for long-term treatment of elderly patients is 7.5 mg) – the symptomatic treatment of ankylosing spondylitis Exclusion Criteria:
- Treatment with MOBEC prior to the start of the study – Patients with any of the general or specific contraindications of MOBEC
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Boehringer Ingelheim
- Provider of Information About this Clinical Study
- Sponsor
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