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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00361504
The ClinicalTrials.gov registry entry for NCT00361504 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxycodone CR is the first listed.
NCT00361504 reports 0 study locations.
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.
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