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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: ABT-712 Extended-release
Drug: Hydrocodone/Acetaminophen Immediate-release
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:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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
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).
Drug: ABT-712 Extended-release
ABT-712 extended-release tablet
Other Names:
  • Hydrocodone/acetaminophen extended-release
  • Hydrocodone bitartrate and acetaminophen extended-release
Drug: Placebo
Placebo tablet
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).
Drug: Hydrocodone/Acetaminophen Immediate-release
Hydrocodone/acetaminophen immediate-release tablet
Drug: Placebo
Placebo tablet
Placebo Comparator: Placebo
2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Drug: Placebo
Placebo tablet

Detailed Description:

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).

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Pedro Quintana Diez, MD AbbVie
  More Information

Additional Information:
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
Results First Received: November 1, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 11, 2014