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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00404222 |
Purpose
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Extended-Release Hydrocodone/Acetaminophen (Vicodin® CR) Drug: Immediate Release Hydrocodone/Acetaminophen (NORCO® ) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Multicenter, Single-Blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following Bunionectomy |
| Estimated Enrollment: | 90 |
| Study Start Date: | November 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | M05-772 |
| Study First Received: | November 26, 2006 |
| Last Updated: | July 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00404222 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Acute Pain following Bunionectomy |
|
Respiratory System Agents Oxycodone Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Hydrocodone Analgesics Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Acetaminophen Analgesics, Opioid |