Safety and Efficacy of Mobic Inj. (Meloxicam) for the Patients With OA or RA: Observational Study
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Arthritis, Rheumatoid
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. Korea Ltd.
Summary
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
Clinical Details
Official title: Regulatory Drug Safety Survey
Study design: N/A
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
Ending date: August 2005
Last updated: June 12, 2008
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