A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery

NCT02197156 | Completed Phase 2

• 1 other identifier: ELN154088-201
• Study Type: interventional
• Target: 241
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)

  0-12 hours

Study Arms (6)

10 mg HC-ER

EXPERIMENTAL

Hydrocodone bitartrate extended release (HC-ER) 10 mg

Drug: 10 mg HC-ER

20 mg HC-ER

EXPERIMENTAL

Hydrocodone bitartrate extended release (HC-ER) 20 mg

Drug: 20 mg HC-ER

30 mg HC-ER

EXPERIMENTAL

Hydrocodone bitartrate extended release (HC-ER) 30 mg

Drug: 30 mg HC-ER

40 mg HC-ER

EXPERIMENTAL

Hydrocodone bitartrate extended release (HC-ER) 40 mg

Drug: 40 mg HC-ER

10 mg HC / 325 mg APAP

ACTIVE COMPARATOR

10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)

Drug: 10 mg HC / 325 mg APAP

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Matching Placebo

Interventions

10 mg HC-ER DRUG

Single dose

Also known as: ELN154088, Hydrocodone bitartrate extended release (HC-ER), Zohydro Extended Release (ER)

10 mg HC-ER

20 mg HC-ER DRUG

Single dose

Also known as: ELN154088, Hydrocodone bitartrate extended release (HC-ER) 10 mg, Zohydro Extended Release (ER)

20 mg HC-ER

30 mg HC-ER DRUG

Single dose

Also known as: ELN154088, Hydrocodone bitartrate extended release (HC-ER) 30 mg, Zohydro Extended Release (ER)

30 mg HC-ER

40 mg HC-ER DRUG

Single dose

Also known as: ELN154088, Hydrocodone bitartrate extended release (HC-ER) 40 mg, Zohydro Extended Release (ER)

40 mg HC-ER

10 mg HC / 325 mg APAP DRUG

Single dose

Also known as: 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)

10 mg HC / 325 mg APAP

Matching Placebo DRUG

Single dose

Also known as: Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject was able to read and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document and given the opportunity to ask questions regarding the study prior to the performance of any study- specific procedures.
• Subject required primary unilateral first metatarsal bunionectomy surgery with or without hammertoe repair with no other collateral procedures allowed
• Subject was male or female at least 18 years of age.
• Subject weighed \> or = 100 lbs (pounds).
• Subject was willing and able to comply with the protocol and able to score their pain intensity.
• Subject was in good health as determined by the investigator on the basis of medical history, physical examination, Electrocardiogram (ECG) and screening laboratory results.
• Subject had not developed a condition or complications as result of the bunionectomy procedure that would preclude their participation in the study.
• Subject was willing and able to remain at the recovery day care center for the entire 24-hour Treatment period.

You may not qualify if:

• Subject was pregnant or lactating.
• Subject had been on an investigational drug within 30 days prior to the initiation of study drug.
• Subject had donated blood or blood components within one month prior to study (Check-in).
• Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or ketorolac.
• Subject had a known history of substance or alcohol abuse within 2 years prior to Screening.
• Subject tested positive to drug screens (cocaine, marijuana, opioids, benzodiazepines, and barbiturates) that could not be justified by prescription use.
• Subject had a condition that would contraindicate the use of opioid analgesia (e.g., pulmonary disease or paralytic ileus).
• Subject had received a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI) carbamazepine, quinidine, and/or tricyclic antidepressants (TCA) compounds within 1-month prior to Check-in.
• Subject had received opioids, tranquilizers, sedatives, or hypnotics within 48 hours prior to Check-in.
• Subject had received corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics within 24 hours prior to Check-in.

Sponsors & Collaborators

• Zogenix, Inc.: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Hydrocodone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 22, 2014
• Study Start: August 1, 2002
• Primary Completion: February 1, 2003
• Study Completion: February 1, 2003
• Last Updated: November 10, 2022

Record last verified: 2014-07