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Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Hydrocodone/Acetaminophen Extended Release (Drug); Acetaminophen (Drug); Morphine Extended Release (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Pedro Quintana Diez, MD, Study Director, Affiliation: AbbVie

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.

Clinical Details

Official title: A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen to Placebo in Subjects With Acute Pain Following Bunionectomy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)

Secondary outcome:

TOTPAR (Total Pain Relief)

Participant's Global Assessment of Study Drug

Time to Perceptible and Meaningful Pain Relief

Participants With Adverse Events (AEs)

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

Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria

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 5 treatment arms. In order to maintain the single-blind nature of the study, all participants were dosed with study drug (active and/or placebo) every 6 hours.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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

Locations and Contacts

Site Reference ID/Investigator# 26223, Peoria, Arizona 85381, United States

Site Reference ID/Investigator# 26302, Austin, Texas 78705, United States

Site Reference ID/Investigator# 26303, San Marcos, Texas 78666, United States

Site Reference ID/Investigator# 26304, West Jordan, Utah 84088, United States

Additional Information

Starting date: December 2009
Last updated: March 10, 2014

Page last updated: August 23, 2015

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