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
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
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
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
No
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
No
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
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A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery
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