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NCT00612885 Clinical Trial

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

Osteoarthritis Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00612885
Other study ID # 107.270
Secondary ID
Status Completed
Phase Phase 4
First received January 30, 2008
Last updated October 31, 2013
Start date March 2004
Est. completion date August 2005

Study information
Verified date October 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Korea, Republic of: KOREA Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 425
Est. completion date August 2005
Est. primary completion date August 2005
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Boehringer Ingelheim Investigational Site Busan
Korea, Republic of Boehringer Ingelheim Investigational Site Chungbuk
Korea, Republic of Boehringer Ingelheim Investigational Site Daegu
Korea, Republic of Boehringer Ingelheim Investigational Site Daejeon
Korea, Republic of Boehringer Ingelheim Investigational Site Gangwondo
Korea, Republic of Boehringer Ingelheim Investigational Site Gwangju
Korea, Republic of Boehringer Ingelheim Investigational Site Gyeongbuk
Korea, Republic of Boehringer Ingelheim Investigational Site Gyeonggido
Korea, Republic of Boehringer Ingelheim Investigational Site Gyeongnam
Korea, Republic of Boehringer Ingelheim Investigational Site Jeonnam
Korea, Republic of Boehringer Ingelheim Investigational Site Seoul

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy assessment by the treating physician up to 3 day No
Primary Combined efficacy, safety and tolerability assessment by the treating physician up tp 3 day No
Primary Incidence of adverse events up tp 3 day No
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