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NCT00986180 · ClinicalTrials.gov registry record · Phase 3
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
A Phase 3 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 667
- Enrollment target
NCT00986180: Completed Phase 3 study, sponsored by Ortho-McNeil Janssen Scientific Affairs.
NCT00986180 is a Phase 3 study that has completed, run by Ortho-McNeil Janssen Scientific Affairs. The registered enrollment target is 667 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00986180, a Phase 3 study, has completed, sponsored by Ortho-McNeil Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 667 participants
- Enrollment target
Study Summary
Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
Primary Outcome
Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.
Interventions
- DRUG Oxycodone IR
- DRUG NUCYNTA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT00986180 record still lists
NCT00986180 is an interventional study that assigns participants to a tested intervention. The registered 667 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 (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxycodone IR is the first listed.
NCT00986180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00986180 about?
NCT00986180 is a clinical study titled "NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain". Evaluate how NUCYNTA (tapentadol) immediate release (IR) compares with oxycodone IR in the treatment of acute low back pain.
What is the current status of trial NCT00986180?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 667 participants. The study started on 2009-09. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00986180?
The interventions under investigation include: Oxycodone IR (DRUG), NUCYNTA (DRUG).
Who is sponsoring clinical trial NCT00986180?
This trial is sponsored by Ortho-McNeil Janssen Scientific Affairs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00986180's enrollment target sits among peer trials
667 551st of 2000 higher than 1,450 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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