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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00612885
Collaborator
(none)
425
Enrollment
11
Locations
17
Duration (Months)
38.6
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    425 participants
    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)
    Study Start Date :
    Mar 1, 2004
    Actual Primary Completion Date :
    Aug 1, 2005
    Actual Study Completion Date :
    Aug 1, 2005

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy assessment by the treating physician [up to 3 day]

    2. Combined efficacy, safety and tolerability assessment by the treating physician [up tp 3 day]

    3. Incidence of adverse events [up tp 3 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boehringer Ingelheim Investigational Site Busan Korea, Republic of
    2 Boehringer Ingelheim Investigational Site Chungbuk Korea, Republic of
    3 Boehringer Ingelheim Investigational Site Daegu Korea, Republic of
    4 Boehringer Ingelheim Investigational Site Daejeon Korea, Republic of
    5 Boehringer Ingelheim Investigational Site Gangwondo Korea, Republic of
    6 Boehringer Ingelheim Investigational Site Gwangju Korea, Republic of
    7 Boehringer Ingelheim Investigational Site Gyeongbuk Korea, Republic of
    8 Boehringer Ingelheim Investigational Site Gyeonggido Korea, Republic of
    9 Boehringer Ingelheim Investigational Site Gyeongnam Korea, Republic of
    10 Boehringer Ingelheim Investigational Site Jeonnam Korea, Republic of
    11 Boehringer Ingelheim Investigational Site Seoul Korea, Republic of

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    • Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Korea Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00612885
    Other Study ID Numbers:
    • 107.270
    First Posted:
    Feb 12, 2008
    Last Update Posted:
    Nov 1, 2013
    Last Verified:
    Oct 1, 2013
    Additional relevant MeSH terms:
    Arthritis
    Osteoarthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Nov 1, 2013