Clinical trial NCT00935311: Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
Secondary outcomes:
measure: TOTPAR (Total Pain Relief)
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
measure: Time to First Rescue Medication
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
measure: Participants With Adverse Events (AEs)
timeFrame: 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).
Other outcomes:
Locations:
city: Austin
country: United States
facility: Site Reference ID/Investigator# 20745
state: Texas
city: San Marcos
country: United States
facility: Site Reference ID/Investigator# 20743
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 20744
state: Utah
Study officials:
affiliation: AbbVie
name: Pedro Quintana Diez, MD
role: STUDY_DIRECTOR
References: