Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

NCT01038609 | Completed Phase 2 Results

• 1 other identifier: M12-058
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

Brief Summary

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

Conditions

Pain

Keywords

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue 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 48 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 48 hours following first study drug administration

Secondary Outcomes (6)

• TOTPAR (Total Pain Relief)

  From time of first study drug administration to 48 hours following first study drug administration

• Participant's Global Assessment of Study Drug

  From time of first study drug administration to 48 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

• Participants With Adverse Events (AEs)

  AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).

• Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria

  At specified intervals from Screening through 7 days after first dose of study drug

Study Arms (5)

Placebo

PLACEBO COMPARATOR

1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).

Drug: Placebo

Acetaminophen

ACTIVE COMPARATOR

1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).

Drug: Acetaminophen

Morphine Extended Release

ACTIVE COMPARATOR

1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).

Drug: Morphine Extended Release

Morphine Extended Release / Acetaminophen

ACTIVE COMPARATOR

1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).

Drug: Acetaminophen; Drug: Morphine Extended Release

Hydrocodone/Acetaminophen Extended Release

EXPERIMENTAL

1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).

Drug: Hydrocodone/Acetaminophen Extended Release

Interventions

Hydrocodone/Acetaminophen Extended Release DRUG

Also known as: ABT-712

Hydrocodone/Acetaminophen Extended Release

Acetaminophen DRUG

Also known as: Tylenol

Acetaminophen; Morphine Extended Release / Acetaminophen

Morphine Extended Release DRUG

Also known as: Kadian

Morphine Extended Release; Morphine Extended Release / Acetaminophen

Placebo DRUG

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 surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures.

You may not qualify if:

• Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures
• Allergic reaction to study medications
• Pregnant or breastfeeding females
• Clinically significant lab abnormalities at screening
• Positive hepatitis testing at screening
• Clinically significant or uncontrolled medical disorders or illness at screening
• Active malignancy or chemotherapy
• Any history of drug or alcohol abuse/addiction
• Known or suspected history of human immunodeficiency virus (HIV); requires treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or butyrophenones
• History of major depressive episode or major psychiatric disorder
• Current systemic corticosteroid therapy
• Inability to refrain from smoking during or alcohol during stay at investigative site

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (4)

Site Reference ID/Investigator# 26223

Peoria, Arizona, 85381, United States

Location

Site Reference ID/Investigator# 26302

Austin, Texas, 78705, United States

Location

Site Reference ID/Investigator# 26303

San Marcos, Texas, 78666, United States

Location

Site Reference ID/Investigator# 26304

West Jordan, Utah, 84088, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Hydrocodone; Acetaminophen; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

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; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 8, 2014
• Results First Posted: March 7, 2014

Record last verified: 2014-03

Locations

US (4)