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Postmarketing Surveillance Study With MOBEC®

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ClinicalTrials.gov Identifier: NCT02182726
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

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

Condition or disease Intervention/treatment
Osteoarthritis Drug: MOBEC

Study Type : Observational
Actual Enrollment : 4760 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COX-2 Postmarketing Surveillance Study With MOBEC® 15 mg Tablets
Study Start Date : May 2001
Actual Primary Completion Date : December 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Group/Cohort Intervention/treatment
MOBEC Drug: MOBEC



Primary Outcome Measures :
  1. Nature and incidence of adverse drug reactions (ADR) [ Time Frame: up to week 8 ]
  2. Assessment of efficacy by physician on a 5-point scale [ Time Frame: up to week 8 ]
  3. Assessment of tolerability by physician on a 5-point scale [ Time Frame: up to week 8 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primarily internal and general medical practices
Criteria

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182726     History of Changes
Other Study ID Numbers: 107.245
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action