Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain

Mallinckrodt

Status and phase

Completed

Phase 3

Conditions

Bunion

Pain, Postoperative

Treatments

Drug: placebo

Drug: COV155

Study type

Interventional

Funder types

Industry

Identifiers

NCT01743625

COV15010232

Details and patient eligibility

About

The purpose of this study is to show the effectiveness of COV155 compared to placebo in subjects with acute moderate to severe pain following bunionectomy surgery.

Enrollment

406 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Voluntarily provide written informed consent
General good health
18 to 75 years of age
Scheduled for primary unilateral first metatarsal bunionectomy (with no collateral procedures)
Body mass index ≤33
Female subjects eligible if
- Not pregnant or lactating; not planning to become pregnant for duration of study;
- Surgically sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or practicing acceptable birth control for more than 2 months prior to Screening, during the study and for 1 week following last dose of COV155
Male subjects must be sterile (biologically or surgically) or use reliable birth control during the study until at least 1 week after the last dose of COV155
Classified as either Physical Status-1 (PS) or PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
Willing to complete pain assessments and clinic visits.
Additional inclusion criterion for randomization into the Double-Blind Phase: Subjects must experience postoperative pain intensity score ≥5 on a 0 to 10 Numerical Pain Rating Score (NPRS) more than 1 hour, and less than 9 hours after discontinuing the nerve block, and at least 30 minutes after the last ice pack has been removed (if used).

Exclusion Criteria

Uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude study participation
Clinically significant abnormal ECG at Screening
Gastric bypass surgery or gastric band
Previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus
History of any medical condition that would alter the absorption, distribution, metabolism or excretion of COV155 including but not limited to severe chronic diarrhea, chronic constipation, severe irritable bowel syndrome, or unexplained weight loss
History of severe bronchial asthma, hypercarbia, hypoxia or sleep apnea
Certain lab abnormalities
Addison's disease, benign prostatic hyperplasia, or kidney disease
Donated blood or blood components within 3 months prior to Screening or during study
Known allergy/hypersensitivity to any opioid analgesics, anesthetics, acetaminophen, non steroidal anti-inflammatory drugs (NSAIDs)
History of intolerance to short term opioid use
Unable to discontinue the use of prohibited medications or a history of substance or alcohol abuse within 2 years prior to Screening or a positive quantitative urine drug test at Screening
Positive for human immunodeficiency virus, hepatitis B or C
Dysphagia and/or cannot swallow study treatment whole
History of migraine or frequent headaches within the previous 2 years, seizures, or are currently taking anticonvulsants
Previously received COV155 in a clinical study, or undergone a bunionectomy within the last 3 months
Received any investigational drugs or devices within 4 weeks prior to Screening or during study
Active malignancy or history of malignancy within 2 years prior to Screening, other than completely eradicated cervical squamous cell carcinoma in situ or basal skin cancer
Currently taking neuroleptics or stable doses of a benzodiazepine
Other criteria as specified in the protocol
Additional exclusion criterion for randomization into the Double-Blind Phase: Have surgical complications that could compromise the safety of the subject or confound the results of the study.