Acute Pain Study Following Bunionectomy

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Hydrocodone/Acetaminophen Extended Release

• Registration Number: NCT01333722
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

Detailed Description

The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Disposition First Submitted: 2012-06-29
• Disposition First Submitted QC: 2012-06-29
• Disposition First Posted: 2012-07-03
• Results First Submitted: 2013-11-01
• Results First Submitted QC: 2014-01-22
• Status Verified: 2014-03
• Results First Posted: 2014-03-07
• Last Update Submitted: 2014-03-10
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy

Exclusion Criteria

• Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
• Drug allergies to hydrocodone, acetaminophen
• Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo, 1 oral tablet every 12 hours
Hydrocodone/Acetaminophen Extended Release	Hydrocodone/Acetaminophen Extended Release	hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)	From time of first study drug administration to 12 hours following first study drug administration	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

Name	Time	Method
SPRID (Pain Relief and Pain Intensity Difference)	From time of first study drug administration to 12 hours following first study drug administration	SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details\*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: "My pain at this time is..." with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID 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.
TOTPAR (Total Pain Relief)	From time of first study drug administration to 12 hours following first study drug administration	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 Perceptible and Meaningful Pain Relief	From time of first study drug administration to 12 hours following first study drug administration	The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.

Trial Locations

Locations (3)

Site Reference ID/Investigator# 51464; 🇺🇸 Pasadena, California, United States

Site Reference ID/Investigator# 51344; 🇺🇸 Salt Lake City, Utah, United States

Site Reference ID/Investigator# 51602; 🇺🇸 Austin, Texas, United States