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Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00935311
First received: June 29, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.


Condition Intervention Phase
Pain
 Drug: Hydrocodone/Acetaminophen Extended Release
Drug: Hydrocodone/Acetaminophen
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Single-blind, Placebo-controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects With Acute Pain Following Third Molar Tooth Extraction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Sum of pain intensity difference [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Rescue medication use [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Throughout the course of the study ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: III Drug: Placebo
Tablet
Experimental: I Drug: Hydrocodone/Acetaminophen Extended Release
Tablet
Active Comparator: II Drug: Hydrocodone/Acetaminophen
Tablet

  Eligibility

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

Inclusion Criteria:

  • Subjects who are in general good health, experiencing moderate pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures

Exclusion Criteria:

  • Allergies to study medications
  • History of multiple drug allergies
  • Unable to stop excluded medications
  • Clinically significant laboratory abnormalities at Screening
  • Significant medical condition at Screening
  • Women who are pregnant or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935311

Locations
United States, Texas
Site Reference ID/Investigator# 20745
Austin, Texas, United States, 78705
Site Reference ID/Investigator# 20743
San Marcos, Texas, United States, 78666
United States, Utah
Site Reference ID/Investigator# 20744
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: NCT00935311     History of Changes
Other Study ID Numbers: M11-063
Study First Received: June 29, 2009
Last Updated: January 14, 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 23, 2013