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Acute Pain Study Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01333722
First received: April 11, 2011
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

The primary purpose of this study is to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following bunionectomy surgery


Condition Intervention Phase
Acute Pain
 Drug: hydrocodone / acetaminophen extended release
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Time-interval weighted Sum of Pain Intensity Difference (SPID) [ Time Frame: 0-12 Hours ] [ Designated as safety issue: No ]
    Pain intensity scores measured using a 100 mm Visual Analog Scale


Secondary Outcome Measures:
  • Time-interval weighted sum of Pain relief (TOTPAR) [ Time Frame: 0-12 hours ] [ Designated as safety issue: No ]
    Pain relief was rated using a 5-point categorial scale

  • Time-interval weighted Sum of Pain Relief and Pain Intensity (SPRID) [ Time Frame: 0-12 Hours ] [ Designated as safety issue: No ]
    Sum of pain relief and pain intensity difference

  • Perceptible and Meaningful Pain Relief [ Time Frame: 12 Hours ] [ Designated as safety issue: No ]
    Times to onset of Perceptible and Meaningful Relief determined using the double-stopwatch method


Enrollment: 99
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hydrocodone / acetaminophen extended release
1 tablet q 12 hours
 Drug: hydrocodone / acetaminophen extended release
1 tablet q 12 hours
Placebo Comparator: Placebo
1 tablet q 12 hours
 Drug: Placebo
1 tablet q 12 hours

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Subjects who are in general good health, experiencing moderate to severe pain following bunionectomy surgery

Exclusion Criteria

  • Subjects who undergo Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
  • Drug allergies to hydrocodone, acetaminophen
  • Clinically significant or uncontrolled medical disorders or illness
  • History of drug or alcohol abuse / addiction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333722

Locations
United States, California
Site Reference ID/Investigator# 51464
Pasadena, California, United States, 91105
United States, Texas
Site Reference ID/Investigator# 51602
Austin, Texas, United States, 78705
United States, Utah
Site Reference ID/Investigator# 51344
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rita Jain, MD AbbVie
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01333722     History of Changes
Other Study ID Numbers: M12-169
Study First Received: April 11, 2011
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013