Back to results

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

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

10 mg HC-ER

20 mg HC-ER

30 mg HC-ER

40 mg HC-ER

10 mg HC / 325 mg APAP

Matching Placebo

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

10 mg HC-ER

20 mg HC-ER

30 mg HC-ER

40 mg HC-ER

10 mg HC / 325 mg APAP

Placebo

Arm Description

Hydrocodone bitartrate extended release (HC-ER) 10 mg

Hydrocodone bitartrate extended release (HC-ER) 20 mg

Hydrocodone bitartrate extended release (HC-ER) 30 mg

Hydrocodone bitartrate extended release (HC-ER) 40 mg

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

Matching placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02197156

First Posted

July 21, 2014

Last Updated

November 8, 2022

Sponsor

Zogenix, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02197156

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

February 2003 (Actual)

Study Completion Date

February 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zogenix, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 mg HC-ER

Arm Type

Experimental

Arm Description

Hydrocodone bitartrate extended release (HC-ER) 10 mg

Arm Title

20 mg HC-ER

Arm Type

Experimental

Arm Description

Hydrocodone bitartrate extended release (HC-ER) 20 mg

Arm Title

30 mg HC-ER

Arm Type

Experimental

Arm Description

Hydrocodone bitartrate extended release (HC-ER) 30 mg

Arm Title

40 mg HC-ER

Arm Type

Experimental

Arm Description

Hydrocodone bitartrate extended release (HC-ER) 40 mg

Arm Title

10 mg HC / 325 mg APAP

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

10 mg HC-ER

Other Intervention Name(s)

ELN154088, Hydrocodone bitartrate extended release (HC-ER), Zohydro Extended Release (ER)

Intervention Description

Single dose

Intervention Type

Drug

Intervention Name(s)

20 mg HC-ER

Other Intervention Name(s)

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

Intervention Description

Single dose

Intervention Type

Drug

Intervention Name(s)

30 mg HC-ER

Other Intervention Name(s)

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

Intervention Description

Single dose

Intervention Type

Drug

Intervention Name(s)

40 mg HC-ER

Other Intervention Name(s)

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

Intervention Description

Single dose

Intervention Type

Drug

Intervention Name(s)

10 mg HC / 325 mg APAP

Other Intervention Name(s)

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

Intervention Description

Single dose

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Other Intervention Name(s)

Placebo

Intervention Description

Single dose

Primary Outcome Measure Information:

Title

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

Time Frame

0-12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs