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

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 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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Meloxicam; Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac

• Study Type: Observational
• Enrollment (Actual): 9984

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence for adverse event of gastrointestinal disorder	up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence for adverse drug reaction of gastrointestinal disorder	up to 6 months
Incidence of adverse events	up to 6 months
Incidence of adverse drug reactions	up to 6 months
Incidence of serious adverse events	up to 6 months
Incidence for adverse events Perforation, Ulcer and Bleeding (PUB) in the upper gastrointestinal tract	up to 6 months

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Bursitis; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Periarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Etodolac; Meloxicam
• Other Study ID Numbers: 107.246