A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Rita Jain, MD, Study Director, Affiliation: Abbott
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Time-interval weighted sum of pain relief (TOTPAR)Time-interval weighted sum of pain intensity (SPID) using the categorical pain intensity scale Time-interval weighted sum of pain relief and pain intensity difference (SPRID) Perceptible pain relief Meaningful pain relief Rescue/supplemental medication use Pain relief (PR) Pain intensity (PI) Subject Global Assessment of Study Drug
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Global Medical Information - Abbott, Abbott Park, Illinois 60064, United States
Additional Information
Starting date: December 2006
Last updated: October 24, 2007
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