Clinical trial NCT01038609: Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Postoperative Pain
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-12-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)
timeFrame: From time of first study drug administration to 48 hours following first study drug administration
Secondary outcomes:
measure: TOTPAR (Total Pain Relief)
timeFrame: From time of first study drug administration to 48 hours following first study drug administration
measure: Participant's Global Assessment of Study Drug
timeFrame: From time of first study drug administration to 48 hours following first study drug administration
measure: Time to Perceptible and Meaningful Pain Relief
timeFrame: From time of first study drug administration to 12 hours following first study drug administration
measure: Participants With Adverse Events (AEs)
timeFrame: 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).
measure: Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria
timeFrame: At specified intervals from Screening through 7 days after first dose of study drug
measure: Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria
timeFrame: At specified intervals from Screening through 7 days after first dose of study drug
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 26223
state: Arizona
city: Austin
country: United States
facility: Site Reference ID/Investigator# 26302
state: Texas
city: San Marcos
country: United States
facility: Site Reference ID/Investigator# 26303
state: Texas
city: West Jordan
country: United States
facility: Site Reference ID/Investigator# 26304
state: Utah
Study officials:
affiliation: AbbVie
name: Pedro Quintana Diez, MD
role: STUDY_DIRECTOR
References: