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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: March 10, 2014
Last verified: March 2014

June 29, 2009
March 10, 2014
June 2009
August 2009   (final data collection date for primary outcome measure)
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ] [ Designated as safety issue: No ]
Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Sum of pain intensity difference [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00935311 on ClinicalTrials.gov Archive Site
  • TOTPAR (Total Pain Relief) [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ] [ Designated as safety issue: No ]
    TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
  • Time to First Rescue Medication [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ] [ Designated as safety issue: No ]
    The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.
  • Participants With Adverse Events (AEs) [ Time Frame: AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days). ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
  • 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: Yes ]
Not Provided
Not Provided
 
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
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

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

Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: ABT-712 Extended-release
    ABT-712 extended-release tablet
    Other Names:
    • Hydrocodone/acetaminophen extended-release
    • Hydrocodone bitartrate and acetaminophen extended-release
  • Drug: Hydrocodone/Acetaminophen Immediate-release
    Hydrocodone/acetaminophen immediate-release tablet
  • Drug: Placebo
    Placebo tablet
  • Experimental: ABT-712
    1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
    Interventions:
    • Drug: ABT-712 Extended-release
    • Drug: Placebo
  • Active Comparator: Hydrocodone/Acetaminophen
    2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
    Interventions:
    • Drug: Hydrocodone/Acetaminophen Immediate-release
    • Drug: Placebo
  • Placebo Comparator: Placebo
    2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who are in general good health, experiencing moderate to severe 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00935311
M11-063
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Pedro Quintana Diez, MD AbbVie
AbbVie
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP