Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935311
• Other study ID #: M11-063
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2009
• Last updated: March 10, 2014
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: March 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• ABT-712 Extended-release
ABT-712 extended-release tablet
• Hydrocodone/Acetaminophen Immediate-release
Hydrocodone/acetaminophen immediate-release tablet
• Placebo
Placebo tablet

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 20745	Austin	Texas
United States	Site Reference ID/Investigator# 20744	Salt Lake City	Utah
United States	Site Reference ID/Investigator# 20743	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)	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.	From time of first study drug administration to 12 hours following first study drug administration	No
Secondary	TOTPAR (Total Pain Relief)	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.	From time of first study drug administration to 12 hours following first study drug administration	No
Secondary	Time to First Rescue Medication	The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.	From time of first study drug administration to 12 hours following first study drug administration	No
Secondary	Participants With Adverse Events (AEs)	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.	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).	Yes

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