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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00612885
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

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 Phase
Osteoarthritis Arthritis, Rheumatoid Phase 4

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 : March 2004
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Meloxicam
U.S. FDA Resources




Primary Outcome Measures :
  1. Efficacy assessment by the treating physician [ Time Frame: up to 3 day ]
  2. Combined efficacy, safety and tolerability assessment by the treating physician [ Time Frame: up tp 3 day ]
  3. Incidence of adverse events [ Time Frame: up tp 3 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612885


Locations
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, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Korea Ltd.

ClinicalTrials.gov Identifier: NCT00612885     History of Changes
Other Study ID Numbers: 107.270
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action