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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180516
• Other study ID #: 107.246
• Status: Completed
• Phase: N/A
• First received: July 1, 2014
• Last updated: July 4, 2014
• Start date: October 2001

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9984
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Periarthritis

Intervention

Drug:
• Meloxicam

• Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence for adverse event of gastrointestinal disorder		up to 6 months	No
Secondary	Incidence for adverse drug reaction of gastrointestinal disorder		up to 6 months	No
Secondary	Incidence of adverse events		up to 6 months	No
Secondary	Incidence of adverse drug reactions		up to 6 months	No
Secondary	Incidence of serious adverse events		up to 6 months	No
Secondary	Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract		up to 6 months	No

External Links

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