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

NCT01743625 | Completed Phase 3

• 1 other identifier: COV15010232
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pain, Postoperative; Bunion

Outcome Measures

Primary Outcomes (1)

• SPID48 (Summed pain intensity difference)

  48 hour Summed pain intensity difference

  48 hours

Secondary Outcomes (3)

• Safety and tolerability of COV155

  48 hours

• Onset of analgesia of COV155 versus placebo

  48 hours

• Analgesic effects of COV155 versus placebo

  48 hours

Study Arms (2)

COV155

EXPERIMENTAL

COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.

Drug: COV155

Placebo

PLACEBO COMPARATOR

Matching tablet to COV155 without containing active ingredients, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.

Drug: placebo

Interventions

COV155 DRUG

COV155 tablets

Also known as: MNK155

COV155

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily provide written informed consent
• General good health
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (5)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Chesapeake Research Group, LLC

Pasadena, Maryland, 21122, United States

Location

Endeavor Clinical Trails, PA

San Antonio, Texas, 78229, United States

Location

Jean Brown Research, Inc.

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Bunion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (5)