Acute Pain Study Following Bunionectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

placebo, 1 oral tablet every 12 hours

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Hydrocodone/Acetaminophen Extended Release

hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours

Group Type EXPERIMENTAL

Hydrocodone/Acetaminophen Extended Release

Intervention Type DRUG

Interventions

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Hydrocodone/Acetaminophen Extended Release

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Other Intervention Names

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ABT-712

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No