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Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01038609
First received: December 22, 2009
Last updated: January 2, 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 compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.


Condition Intervention Phase
Pain
 Drug: Hydrocodone/acetaminophen extended release
Drug: Morphine Extended Release
Drug: Acetaminophen
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen 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: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-interval weighted sum of pain relief (TOTPAR) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Subject's global assessment of study drug [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Assessment of perceptible and meaningful pain relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Adverse events,vital signs, laboratory parameters [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocodone/acetaminophen extended release Drug: Hydrocodone/acetaminophen extended release
1 tablet every 12 hours
Other Name: ABT-712
Active Comparator: Morphine Extended Release Drug: Morphine Extended Release
1 capsule every 12 hours
Other Name: Kadian
Active Comparator: Acetaminophen Drug: Acetaminophen
1 tablet every 6 hours
Other Name: Tylenol
Active Comparator: Morphine Extended Release and Acetaminophen Drug: Morphine Extended Release
1 capsule every 12 hours
Other Name: Kadian
Drug: Acetaminophen
1 tablet every 6 hours
Other Name: Tylenol
Placebo Comparator: Placebo Drug: Placebo
1 tablet every 6 hours
Other Name: Placebo

  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 and who are willing to remain confined until for approximately 4 days following surgery for study procedures.

Exclusion Criteria:

  • Subjects who undergo Base wedge osteotomy and/or Long-Z hart bunionectomy procedures
  • Allergic reaction to study medications
  • Pregnant or breastfeeding females
  • Clinically significant lab abnormalities at screening
  • Positive hepatitis testing at screening
  • Clinically significant or uncontrolled medical disorders or illness at screening
  • Active malignancy or chemotherapy
  • Any history of drug or alcohol abuse/addiction
  • Known or suspected history of HIV; requires treatment with MAOIs, TCAs or butyrophenones
  • History of major depressive episode or major psychiatric disorder
  • Current systemic corticosteroid therapy
  • Inability to refrain from smoking during or alcohol during stay at investigative site.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038609

Locations
United States, Arizona
Site Reference ID/Investigator# 26223
Peoria, Arizona, United States, 85381
United States, Texas
Site Reference ID/Investigator# 26302
Austin, Texas, United States, 78705
Site Reference ID/Investigator# 26303
San Marcos, Texas, United States, 78666
United States, Utah
Site Reference ID/Investigator# 26304
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jerry A Hall, 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: NCT01038609     History of Changes
Other Study ID Numbers: M12-058
Study First Received: December 22, 2009
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Postoperative Pain

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Morphine
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 23, 2013