A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery
NCT ID: NCT02197156
Last Updated: 2022-11-10
Study Results
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Basic Information
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COMPLETED
PHASE2
241 participants
INTERVENTIONAL
2002-08-31
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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10 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 10 mg
10 mg HC-ER
Single dose
20 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 20 mg
20 mg HC-ER
Single dose
30 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 30 mg
30 mg HC-ER
Single dose
40 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 40 mg
40 mg HC-ER
Single dose
10 mg HC / 325 mg APAP
10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)
10 mg HC / 325 mg APAP
Single dose
Placebo
Matching placebo
Matching Placebo
Single dose
Interventions
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10 mg HC-ER
Single dose
20 mg HC-ER
Single dose
30 mg HC-ER
Single dose
40 mg HC-ER
Single dose
10 mg HC / 325 mg APAP
Single dose
Matching Placebo
Single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Zogenix, Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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ELN154088-201
Identifier Type: -
Identifier Source: org_study_id
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