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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00364533
The ClinicalTrials.gov registry entry for NCT00364533 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 367 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 3 interventions - of which Placebo is the first listed.
NCT00364533 reports 0 study locations.
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.
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