Clinical trial NCT00402792: A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Acute pain following bunionectomy surgery
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 150
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 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.


Eligibility 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

Primary outcomes:
measure: 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.
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: Perceptible pain relief
timeFrame: 12 hours
measure: Meaningful pain relief
timeFrame: 12 hours
measure: Pain relief (PR)
timeFrame: 12 hours
measure: Pain intensity (PI)
timeFrame: 12 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: Site Ref # / Investigator 2589
state: Texas
city: Houston
country: United States
facility: Site Ref # / Investigator 2587
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 2586
state: Texas
city: San Marcos
country: United States
facility: Site Ref # / Investigator 2588
state: Texas
city: Salt Lake City
country: United States
facility: Site Ref # / Investigator 2585
state: Utah
Study officials:
affiliation: Abbott
name: Rita Jain, MD
role: STUDY_DIRECTOR
References: