A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
CompletedPhase 3NCT00361504
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Brief summary (from the registry)
The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.
Study details
- Official title
- A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain
- Interventions
- Drug: Oxycodone CR
- Drug: Tapentadol (CG5503) ER
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Collaborators
- Grünenthal GmbH
- Start date
- 2006-11
- Primary completion
- 2008-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Canada, United States
- Total sites listed
- 52
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months * Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen * Have a pain intensity \>4 on Numerical Rating Scale Exclusion Criteria: * Life-long history of seizure disorder or epilepsy * Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm * Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness * History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma * Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
Canadian sites (12)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00361504