NCT00402792CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 150
- Locations
- 5
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1: hydrocodone / acetaminophen extended release
Experimental
Intervention: Hydrocodone/Acetaminophen Extended-Release (Drug)
Arm 2: hydrocodone / acetaminophen extended release
Experimental
Intervention: Hydrocodone/Acetaminophen Extended Release (Drug)
Arm 3: Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)
Secondary Outcomes
- Perceptible pain relief(12 hours)
- Meaningful pain relief(12 hours)
- Pain relief (PR)(12 hours)
- Pain intensity (PI)(12 hours)
- Time-interval weighted sum of pain relief (TOTPAR)(12 hours)
- Time-interval weighted sum of pain relief and pain intensity difference (SPRID)(12 hours)
Investigators
Study Sites (5)
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