Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study

Official Title: “Regulatory Drug Safety Survey”

This PMS study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:

1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))

2. Frequency of incidence and its change in adverse events (AEs)

3. Factors on the safety profile of the study drug

4. Factors on the efficacy profile of the study drug

INCLUSION CRITERIA:

• diagnosed as osteoarthritis and rheumatoid arthritis

EXCLUSION CRITERIA:

• 1. Known hypersensitivity to meloxicam
• 2. Cross hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs
• 3. Symptoms of asthma, rhinitis, angioneurotic edema, or urticaria following the administration of aspirin or other NSAIDs
• 4. Active peptic ulceration
• 5. Severe hepatic failure.
• 6. Non-dialysed severe renal insufficiency
• 7. Children and adolescents aged 15 years or less
• 8. Pregnancy or breastfeeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair B.I. Korea Ltd.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612885

Study ID Number: 107.270

ClinicalTrials.gov Identifier: NCT00612885

Health Authority: Korea, Republic of: KOREA Food and Drug Administration (KFDA)