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

NCT ID: NCT00612885

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Arthritis, Rheumatoid

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Korea Ltd.

Locations

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Boehringer Ingelheim Investigational Site

Busan, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Daegu, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Daejeon, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Gangwondo, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Gwangju, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Gyeongbuk, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Gyeonggido, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Gyeongnam, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Jeonnam, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Jungbuk, , South Korea

Site Status

Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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107.270

Identifier Type: -

Identifier Source: org_study_id