Acute Pain Study Following Bunionectomy

NCT01333722 | Completed Phase 2 Results

• 1 other identifier: M12-169
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• TOTPAR (Total Pain Relief)

  From time of first study drug administration to 12 hours following first study drug administration

• SPRID (Pain Relief and Pain Intensity Difference)

  From time of first study drug administration to 12 hours following first study drug administration

• Time to Perceptible and Meaningful Pain Relief

  From time of first study drug administration to 12 hours following first study drug administration

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo, 1 oral tablet every 12 hours

Drug: Placebo

Hydrocodone/Acetaminophen Extended Release

EXPERIMENTAL

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

Drug: Hydrocodone/Acetaminophen Extended Release

Interventions

Hydrocodone/Acetaminophen Extended Release DRUG

Also known as: ABT-712

Hydrocodone/Acetaminophen Extended Release

Placebo DRUG

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (3)

Site Reference ID/Investigator# 51464

Pasadena, California, 91105, United States

Location

Site Reference ID/Investigator# 51602

Austin, Texas, 78705, United States

Location

Site Reference ID/Investigator# 51344

Salt Lake City, Utah, 84117, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pain

Interventions

Hydrocodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Pedro Quintana Diez, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 8, 2014
• Results First Posted: March 7, 2014

Record last verified: 2014-03

Locations

US (3)