Acute Pain Study Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01333722
First received: April 11, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Hydrocodone/Acetaminophen Extended Release
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • TOTPAR (Total Pain Relief) [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ] [ Designated as safety issue: No ]
    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.

  • SPRID (Pain Relief and Pain Intensity Difference) [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ] [ Designated as safety issue: No ]
    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.

  • Time to Perceptible and Meaningful Pain Relief [ Time Frame: From time of first study drug administration to 12 hours following first study drug administration ] [ Designated as safety issue: No ]
    The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.


Enrollment: 100
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo, 1 oral tablet every 12 hours
Drug: Placebo
Placebo tablet
Experimental: Hydrocodone/Acetaminophen Extended Release
hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
Drug: Hydrocodone/Acetaminophen Extended Release
Other Name: ABT-712

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333722

Locations
United States, California
Site Reference ID/Investigator# 51464
Pasadena, California, United States, 91105
United States, Texas
Site Reference ID/Investigator# 51602
Austin, Texas, United States, 78705
United States, Utah
Site Reference ID/Investigator# 51344
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Pedro Quintana Diez, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01333722     History of Changes
Other Study ID Numbers: M12-169
Study First Received: April 11, 2011
Results First Received: November 1, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 01, 2014