A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00402792
First received: November 20, 2006
Last updated: January 24, 2011
Last verified: January 2011
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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 compared to 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Hydrocodone/Acetaminophen Extended-Release Drug: Hydrocodone/Acetaminophen Extended Release Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)
Secondary Outcome Measures:
- Time-interval weighted sum of pain relief (TOTPAR) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Time-interval weighted sum of pain relief and pain intensity difference (SPRID) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Perceptible pain relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Meaningful pain relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Pain relief (PR) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Pain intensity (PI) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
| Enrollment: | 150 |
| Study Start Date: | December 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: hydrocodone / acetaminophen extended release |
Drug: Hydrocodone/Acetaminophen Extended-Release
1 tablet q 12 hours
Other Names:
|
| Experimental: Arm 2: hydrocodone / acetaminophen extended release |
Drug: Hydrocodone/Acetaminophen Extended Release
2 tablets q 12 hours
Other Names:
|
| Placebo Comparator: Arm 3: Placebo |
Drug: Placebo
2 tablets q 12 hours
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females ages 18 to 65
- Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
- Meet specific pain intensity criteria on the morning after surgery
- Willing to be confined for 4 days following surgery
- If female, must be of non-child bearing potential or practicing birth control
Exclusion Criteria:
- Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
- Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
- Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract
- Has specific active or uncontrolled seizure disorders
- Has been diagnosed with certain cancers within the past 5 years
- Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression
- Has specific clinically significant illnesses or laboratory abnormalities
- Has received corticosteroid treatment or any investigational drug within a specific timeframe
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402792
Locations
| United States, Texas | |
| Site Ref # / Investigator 2589 | |
| Austin, Texas, United States, 78705 | |
| Site Ref # / Investigator 2587 | |
| Houston, Texas, United States, 77081 | |
| Site Ref # / Investigator 2586 | |
| San Antonio, Texas, United States, 78229 | |
| Site Ref # / Investigator 2588 | |
| San Marcos, Texas, United States, 78666 | |
| United States, Utah | |
| Site Ref # / Investigator 2585 | |
| Salt Lake City, Utah, United States, 84094 | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Rita Jain, MD | Abbott |
More Information
No publications provided
| Responsible Party: | Andrea Best, DO, MPH, Abbott |
| ClinicalTrials.gov Identifier: | NCT00402792 History of Changes |
| Other Study ID Numbers: | M05-765 |
| Study First Received: | November 20, 2006 |
| Last Updated: | January 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
|
Acute pain following bunionectomy surgery |
Additional relevant MeSH terms:
|
Acetaminophen Acetaminophen, hydrocodone drug combination Hydrocodone Oxycodone Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013