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NCT00364533 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Terminated
- Registry status
- Phase 3
- Development phase
- 367
- Enrollment target
NCT00364533: Clinical Trial Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00364533 is a Phase 3 study that was terminated before completion, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 367 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00364533, a Phase 3 study, was terminated before completion, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 367 participants
- Enrollment target
Study Summary
The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.
Primary Outcome
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.
Interventions
- DRUG Placebo
- DRUG Tapentadol IR (CG5503)
- DRUG Oxycodone HCL IR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
Why NCT00364533 stopped before completion
NCT00364533 is an interventional study that assigns participants to a tested intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00364533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00364533 about?
NCT00364533 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety". The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the dr...
What is the current status of trial NCT00364533?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 367 participants. The study started on 2006-10. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00364533?
The interventions under investigation include: Placebo (DRUG), Tapentadol IR (CG5503) (DRUG), Oxycodone HCL IR (DRUG).
Who is sponsoring clinical trial NCT00364533?
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 NCT00364533's enrollment target sits among peer trials
367 998th of 2000 higher than 1,002 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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