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

Zogenix

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: 20 mg HC-ER; Drug: 40 mg HC-ER; Drug: Matching Placebo; Drug: 30 mg HC-ER; Drug: 10 mg HC-ER; Drug: 10 mg HC / 325 mg APAP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02197156

ELN154088-201

Details and patient eligibility

About

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

Full 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

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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241 participants in 6 patient groups, including a placebo group

10 mg HC-ER

Experimental group

Description:

Hydrocodone bitartrate extended release (HC-ER) 10 mg

Treatment:

Drug: 10 mg HC-ER

20 mg HC-ER

Experimental group

Description:

Hydrocodone bitartrate extended release (HC-ER) 20 mg

Treatment:

Drug: 20 mg HC-ER

30 mg HC-ER

Experimental group

Description:

Hydrocodone bitartrate extended release (HC-ER) 30 mg

Treatment:

Drug: 30 mg HC-ER

40 mg HC-ER

Experimental group

Description:

Hydrocodone bitartrate extended release (HC-ER) 40 mg

Treatment:

Drug: 40 mg HC-ER

10 mg HC / 325 mg APAP

Active Comparator group

Description:

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

Treatment:

Drug: 10 mg HC / 325 mg APAP

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Matching Placebo