A Study Comparing Vicodin® CR and NORCO® to Placebo 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); Immediate Release Hydrocodone/Acetaminophen (NORCO® ) (Drug)
Phase: Phase 2
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 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.
Clinical Details
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
Study design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours 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) Time to first noticeable pain relief (i.e., onset of pain relief) Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline Time to rescue medication Proportion of subjects using rescue medication Proportion of subjects experiencing meaningful pain relief after dosing Mean pain relief and pain intensity at each scheduled pain evaluation and the subject global evaluation
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females ages 18 to 65
- Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
- Must meet specific pain intensity criteria on the morning after surgery
- Willing to remain at the study center 2 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, hydromorphone, oxycodone,
acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
- Is allergic to or has a serious reaction to aspirin or other non-steroidal
anti-inflammatory drugs (NSAIDs)
- Has a history of or currently has any active seizure disorder
- Has a history of or any disease causing severe gastrointestinal narrowing or slowing
down the gastrointestinal tract
- Has been diagnosed with cancer within the past 3 years
- Requires treatment with certain drugs for depression or psychiatric disorders
- Has specific clinically significant illnesses or laboratory abnormalities
- Received corticosteroid treatment or any investigational drug within a specific
timeframe.
Locations and Contacts
Additional Information
Starting date: November 2005
Last updated: July 23, 2007
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