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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 is a Phase 2 study that has completed, run by Abbott. The registered enrollment target is 210 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00404391
The ClinicalTrials.gov registry entry for NCT00404391 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott, which has 181 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00404391 reports 0 study locations.
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.
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