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

November 8, 2022 updated by: Zogenix, Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Matching Placebo
Single dose
Other Names:
  • Placebo
Experimental: 10 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 10 mg
Drug: 10 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Hydrocodone bitartrate extended release (HC-ER)
  • Zohydro Extended Release (ER)
Experimental: 20 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 20 mg
Drug: 20 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Zohydro Extended Release (ER)
  • Hydrocodone bitartrate extended release (HC-ER) 10 mg
Experimental: 30 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 30 mg
Drug: 30 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Zohydro Extended Release (ER)
  • Hydrocodone bitartrate extended release (HC-ER) 30 mg
Experimental: 40 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 40 mg
Drug: 40 mg HC-ER
Single dose
Other Names:
  • ELN154088
  • Zohydro Extended Release (ER)
  • Hydrocodone bitartrate extended release (HC-ER) 40 mg
Active Comparator: 10 mg HC / 325 mg APAP
10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)
Drug: 10 mg HC / 325 mg APAP
Single dose
Other Names:
  • 10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)
Time Frame: 0-12 hours
0-12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zogenix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELN154088-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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