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Completed

NCT Number: NCT01333722

Acute Pain Study Following Bunionectomy

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocodone/Acetaminophen Extended Release

Drug

Other names: ABT-712

Placebo

Drug

Placebo tablet

Primary outcomes

  1. Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)

    Time frame: 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 outcomes

  1. TOTPAR (Total Pain Relief)

    Time frame: 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.

  2. SPRID (Pain Relief and Pain Intensity Difference)

    Time frame: 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.

  3. Time to Perceptible and Meaningful Pain Relief

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 12, 2011
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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