Acute Pain Study Following Bunionectomy

Pain Clinical Trial

Official title:

A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333722
• Other study ID #: M12-169
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2011
• Last updated: March 10, 2014
• Start date: April 2011
• Est. completion date: June 2011

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain

Intervention

Drug:
• Hydrocodone/Acetaminophen Extended Release

• Placebo
Placebo tablet

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 51602	Austin	Texas
United States	Site Reference ID/Investigator# 51464	Pasadena	California
United States	Site Reference ID/Investigator# 51344	Salt Lake City	Utah

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	SPRID (Pain Relief and Pain Intensity Difference)	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.	From time of first study drug administration to 12 hours following first study drug administration	No
Secondary	Time to Perceptible and Meaningful Pain Relief	The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.	From time of first study drug administration to 12 hours following first study drug administration	No

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