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Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study
This study has been completed.
First Received: January 30, 2008   Last Updated: June 12, 2008   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00612885
  Purpose

This PMS study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:

  1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
  2. Frequency of incidence and its change in adverse events (AEs)
  3. Factors on the safety profile of the study drug
  4. Factors on the efficacy profile of the study drug

Condition Phase
Osteoarthritis
Arthritis, Rheumatoid
 Phase IV

Study Type: Observational
Official Title: Regulatory Drug Safety Survey

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Rheumatoid Arthritis
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Estimated Enrollment: 600
Estimated Study Completion Date: August 2005
  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
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
Seoul, 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
Gwangju, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Korea Ltd.
  More Information

No publications provided

Study ID Numbers: 107.270
Study First Received: January 30, 2008
Last Updated: June 12, 2008
ClinicalTrials.gov Identifier: NCT00612885     History of Changes
Health Authority: Korea, Republic of: KOREA Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
 Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 08, 2010



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