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Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome

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ClinicalTrials.gov Identifier: NCT02180516
Recruitment Status : Completed
First Posted : July 2, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the safety profile of meloxicam by comparing incidence of gastrointestinal adverse events of meloxicam with that of NSAID in the routine daily therapeutic situation.

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Drug: Meloxicam Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac

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Study Type : Observational
Actual Enrollment : 9984 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome
Study Start Date : October 2001
Actual Primary Completion Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam

Group/Cohort Intervention/treatment
Meloxicam Drug: Meloxicam
Other NSAIDs Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac



Primary Outcome Measures :
  1. Incidence for adverse event of gastrointestinal disorder [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Incidence for adverse drug reaction of gastrointestinal disorder [ Time Frame: up to 6 months ]
  2. Incidence of adverse events [ Time Frame: up to 6 months ]
  3. Incidence of adverse drug reactions [ Time Frame: up to 6 months ]
  4. Incidence of serious adverse events [ Time Frame: up to 6 months ]
  5. Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract [ Time Frame: up to 6 months ]


Information from the National Library of Medicine

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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
Patients from hospitals or general practioners (Internal Medicine, Orthopedics)
Criteria

Inclusion Criteria:

  • Patients with Indications according to the package insert of the prescribed NSAID

Exclusion Criteria:

  • There is no exclusion criterion, because this Post Marketing Study is an observational study

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02180516     History of Changes
Other Study ID Numbers: 107.246
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bursitis
Meloxicam
Etodolac
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action