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NCT00361504 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 1,123
- Enrollment target
NCT00361504: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00361504 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 1,123 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00361504, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,123 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.
Interventions
- DRUG Oxycodone CR
- DRUG Tapentadol (CG5503) ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,123 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00361504 record still lists
NCT00361504 is an interventional study that assigns participants to a tested intervention. Its 1,123 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which Oxycodone CR is the first listed.
NCT00361504 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00361504 about?
NCT00361504 is a clinical study titled "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". 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.
What is the current status of trial NCT00361504?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,123 participants. The study started on 2006-11. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00361504?
The interventions under investigation include: Oxycodone CR (DRUG), Tapentadol (CG5503) ER (DRUG).
Who is sponsoring clinical trial NCT00361504?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00361504's enrollment target sits among peer trials
1,123 248th of 2000 higher than 1,752 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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