A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404222
• Other study ID #: M05-772
• Status: Completed
• Phase: Phase 2
• First received: November 26, 2006
• Last updated: July 22, 2011
• Start date: November 2005
• Est. completion date: February 2006

Study information

• Verified date: July 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• Hydrocodone/Acetaminophen Extended-Release
2 tablets x 1
• Hydrocodone/Acetaminophen Immediate Release (NORCO®)
1 tablet q 4 hours x 3
• Placebo
q 4 hours x 3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 hours	No
Primary	Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS)		12 hours	No
Secondary	Time-interval weighted sum of pain relief (TOTPAR)		12 hours	No
Secondary	Time-interval weighted sum of pain relief and pain intensity difference (SPRID)		12 hours	No
Secondary	Time to first noticeable pain relief (i.e., onset of pain relief)		12 hours	No
Secondary	Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline)		12 hours	No
Secondary	Proportion of subjects experiencing meaningful pain relief after dosing		12 hours	No