Phase 2 N=122 Randomized Triple-blind Treatment

Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

Pain

Bottom Line

View on ClinicalTrials.gov: NCT00935311 ↗

Enrolled (actual)

122

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) — 268.8; 230.9; 54.8 scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ABT-712 Extended-release (Drug); Hydrocodone/Acetaminophen Immediate-release (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie (prior sponsor, Abbott)
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)	268.8; 230.9; 54.8	—
SECONDARY TOTPAR (Total Pain Relief)	18.0; 15.9; 10.5	—
SECONDARY Time to First Rescue Medication	442.0; 205.0; 123.5	—
SECONDARY Participants With Adverse Events (AEs)	14; 12; 14; 5; 8; 4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00935311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.