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NCT00404391 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery
A Phase 2 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
NCT00404391: Completed Phase 2 study, sponsored by Abbott.
NCT00404391 is a Phase 2 study that has completed, run by Abbott. The registered enrollment target is 210 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00404391, a Phase 2 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 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 Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
Primary Outcome
Pain relief measured by a 100mm Visual Analog Scale (VAS)
Interventions
- DRUG Placebo
- DRUG Hydrocodone/Acetaminophen Extended Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2003-10 |
| Est. Completion | 2004-03 |
| Phase | Phase 2 |
What the finished NCT00404391 record still lists
NCT00404391 is an interventional study that assigns participants to a tested intervention. The registered 210 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 (58% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00404391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00404391 about?
NCT00404391 is a clinical study titled "A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery". 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 Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safe...
What is the current status of trial NCT00404391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2003-10. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00404391?
The interventions under investigation include: Placebo (DRUG), Hydrocodone/Acetaminophen Extended Release (DRUG).
Who is sponsoring clinical trial NCT00404391?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00404391's enrollment target sits among peer trials
210 290th of 2000 higher than 1,707 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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