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

Post Marketing Surveillance to Assess the Safety and Efficacy of Mobic® (Meloxicam) Intramuscular Injection (7.5mg ~ 15mg, q.d.) up to 3 Days (in Case of Need for Prolonged Treatment, Switch to Mobic® Capsule Therapy Was Possible) in Korean Patients With Osteoarthritis and Rheumatoid Arthritis (KFDA Regulatory Requirement PMS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00612885

Enrollment

425

Registered

2008-02-12

Start date

2004-03-31

Completion date

2005-08-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid, Osteoarthritis

Brief summary

The main objective of this PMS study was to monitor and assess the safety of Mobic® intramuscular injection (7.5mg \ 15mg, q.d.) up to 3 days (in case of need for prolonged treatment, switch to Mobic® capsule therapy was possible) in Korean patients with osteoarthritis and rheumatoid arthritis.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy assessment by the treating physician	up to 3 day
Combined efficacy, safety and tolerability assessment by the treating physician	up tp 3 day
Incidence of adverse events	up tp 3 day

Countries

South Korea

Outcome results