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NCT01038609 · ClinicalTrials.gov registry record · Phase 2
Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy
A Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT01038609: Completed Phase 2 study, sponsored by AbbVie (prior sponsor, Abbott).
NCT01038609 is a Phase 2 study that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01038609, a Phase 2 study, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.
Primary Outcome
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated usin
Interventions
- DRUG Placebo
- DRUG Acetaminophen
- DRUG Hydrocodone/Acetaminophen Extended Release
- DRUG Morphine Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT01038609 record still lists
NCT01038609 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01038609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01038609 about?
NCT01038609 is a clinical study titled "Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy". The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.
What is the current status of trial NCT01038609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2009-12. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01038609?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Hydrocodone/Acetaminophen Extended Release (DRUG), Morphine Extended Release (DRUG).
Who is sponsoring clinical trial NCT01038609?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01038609's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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