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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