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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00612885
First received: January 30, 2008
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Phase
Osteoarthritis
Arthritis, Rheumatoid
Phase 4

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Efficacy assessment by the treating physician [ Time Frame: up to 3 day ] [ Designated as safety issue: No ]
  • Combined efficacy, safety and tolerability assessment by the treating physician [ Time Frame: up tp 3 day ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up tp 3 day ] [ Designated as safety issue: No ]

Enrollment: 425
Study Start Date: March 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00612885     History of Changes
Other Study ID Numbers: 107.270
Study First Received: January 30, 2008
Last Updated: October 31, 2013
Health Authority: Korea, Republic of: KOREA Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014