Clinical trial NCT00404222: A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Acute Pain following Bunionectomy
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-11-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 12 hours
measure: Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)
timeFrame: 12 hours
Secondary outcomes:
measure: Time-interval weighted sum of pain relief (TOTPAR)
timeFrame: 12 hours
measure: Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
timeFrame: 12 hours
measure: Time to first noticeable pain relief (i.e., onset of pain relief)
timeFrame: 12 hours
measure: Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)
timeFrame: 12 hours
measure: Proportion of subjects experiencing meaningful pain relief after dosing
timeFrame: 12 hours
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Rita Jain, MD
role: STUDY_DIRECTOR
References: