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NCT02487108 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 569
- Enrollment target
NCT02487108: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02487108 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 569 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02487108, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 569 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating participants with moderate to severe pain following bunionectomy.
Primary Outcome
The SPID48 was calculated as the time-weighted sum of pain intensity difference (PID) at each time point over 48 hours. The SPID48 was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. Least square (LS) mean was calculated using an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data.
Interventions
- DRUG Placebo
- DRUG TV-46763
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 569 participants |
| Start Date | 2015-08-11 |
| Est. Completion | 2016-03-30 |
| Phase | Phase 3 |
What the finished NCT02487108 record still lists
NCT02487108 is an interventional study that assigns participants to a tested intervention. The registered 569 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 (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02487108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02487108 about?
NCT02487108 is a clinical study titled "Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy". The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating participants with moderate to sever...
What is the current status of trial NCT02487108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 569 participants. The study started on 2015-08-11. Estimated completion is 2016-03-30.
What interventions are being tested in trial NCT02487108?
The interventions under investigation include: Placebo (DRUG), TV-46763 (DRUG).
Who is sponsoring clinical trial NCT02487108?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02487108's enrollment target sits among peer trials
569 666th of 2000 higher than 1,335 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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