A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain
CompletedPhase 3NCT00364546
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 chronic pain.
Study details
- Official title
- A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
- Conditions
- Osteoarthritis
- Pain Intensity Assessment
- Arthralgia
- Sciatica
- Low Back Pain
- Interventions
- Drug: CG 5503
- tapentadol
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Collaborators
- Grünenthal GmbH
- Start date
- 2006-07
- Primary completion
- 2007-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00364546