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

This study has been completed.

Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00404222
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Extended-Release Hydrocodone/Acetaminophen (Vicodin® CR)
Drug: Immediate Release Hydrocodone/Acetaminophen (NORCO® )
Phase II

Drug Information available for:   Acetaminophen    Hydrocodone    Hydrocodone bitartrate    Vicodin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment:   90
Study Start Date:   November 2005

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404222

Sponsors and Collaborators
Abbott

Investigators
Study Director:     Rita Jain, MD     Abbott    
  More Information


Study ID Numbers:   M05-772
First Received:   November 26, 2006
Last Updated:   July 23, 2007
ClinicalTrials.gov Identifier:   NCT00404222
Health Authority:   United States: Food and Drug Administration

Keywords provided by Abbott:
Acute Pain following Bunionectomy  

Study placed in the following topic categories:
Naphazoline
Oxymetazoline
Guaifenesin
Phenylephrine
Hydrocodone
Pain
Phenylpropanolamine
Acetaminophen

Additional relevant MeSH terms:
Respiratory System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 20, 2008




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