Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

AbbVie

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Morphine Extended Release; Drug: Acetaminophen; Drug: Hydrocodone/Acetaminophen Extended Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01038609

M12-058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo

Acetaminophen

Active Comparator group

Description:

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).

Treatment:

Drug: Acetaminophen

Morphine Extended Release

Active Comparator group

Description:

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).

Treatment:

Drug: Morphine Extended Release

Morphine Extended Release / Acetaminophen

Active Comparator group

Description:

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).

Treatment:

Drug: Acetaminophen

Drug: Morphine Extended Release

Hydrocodone/Acetaminophen Extended Release

Experimental group

Description:

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).

Treatment:

Drug: Hydrocodone/Acetaminophen Extended Release