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NCT00613938 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 901
- Enrollment target
NCT00613938: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00613938 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 901 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613938, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 901 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
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. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with acti
Interventions
- DRUG placebo
- DRUG oxycodone
- DRUG Tapentadol (CG5503)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 901 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00613938 record still lists
NCT00613938 is an interventional study that assigns participants to a tested intervention. The registered 901 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00613938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00613938 about?
NCT00613938 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.". The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.
What is the current status of trial NCT00613938?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 901 participants. The study started on 2008-02. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00613938?
The interventions under investigation include: placebo (DRUG), oxycodone (DRUG), Tapentadol (CG5503) (DRUG).
Who is sponsoring clinical trial NCT00613938?
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 NCT00613938's enrollment target sits among peer trials
901 349th of 2000 higher than 1,651 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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