Status:
COMPLETED
A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Osteoarthritis
Pain Intensity Assessment
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have ...
Detailed Description
CG5503 is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study is designed to assess the safety of CG5503 Immediate Release (IR) in men and...
Eligibility Criteria
Inclusion
- A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months
- require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder
- post-washout baseline pain intensity score \>4 on an 11-point numerical rating scale
Exclusion
- History of seizure disorder or epilepsy
- uncontrolled hypertension
- currently treated with monoamine oxidase inhibitors
- systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening
- history of malignancy within the past 2 years, with the exception of basal cell carcinoma
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
877 Patients enrolled
Trial Details
Trial ID
NCT00364546
Start Date
July 1 2006
End Date
July 1 2007
Last Update
June 9 2011
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