Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension

NCT01484652 | Completed Phase 3 Results

• 1 other identifier: COV15000182
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective of this study is to show the effectiveness of repeated doses of COV795 versus placebo, using the summed pain intensity difference over the first 48 hours in subjects with acute moderate to severe pain following bunionectomy.

Conditions

Pain, Postoperative; Bunion

Keywords

Moderate Post-Operative Pain; Severe Post-Operative Pain; Bunionectomy

Outcome Measures

Primary Outcomes (1)

• SPID48 (Summed Pain Intensity Difference)

  Pain intensity (PI) is measured using the 11-point (0-10) Numeric Pain Rating Scale (NPRS) score. PID is the arithmetic difference in NPRS score at the time point of interest from the baseline score. SPID48 is the sum of time-weighted PID scores measured 22 times over the 48 hour assessment period, with a total score ranging from -480 (worst) to 480 (best). A higher SPID value indicates greater pain relief.

  48 hours

Study Arms (2)

COV795

EXPERIMENTAL

Drug: COV795

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

COV795 DRUG

2 tablets taken every 12 hours

Also known as: MNK795

COV795

Placebo DRUG

2 tablets taken every 12 hours

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete the informed consent process as documented by signed informed consent form(s).
• Be in generally good health.
• Be 18 to 75 years of age, inclusively at the time of screening.
• Be scheduled for a primary unilateral first metatarsal bunionectomy (with no collateral procedures).
• Have a body mass index ≤33 kg/m2.
• Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant for the duration of the study, surgically sterile or at least two years postmenopausal, or practicing an acceptable form of birth control for at least 2 months
• Male subjects must be sterile or commit to the use of a reliable method of birth control
• Be classified as Physical status 1 (PS-1) to PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
• Be willing to complete the pain evaluations and return to the clinic as scheduled.

You may not qualify if:

• Have an uncontrolled medical condition, serious intercurrent illness, clinically significant general health condition, or extenuating circumstance that may significantly decrease study compliance or otherwise preclude their participation in the study.
• Have a clinically significant abnormal electrocardiogram (ECG) at screening
• Have had any type of gastric bypass surgery or have a gastric band.
• Have previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus.
• Have a history of any medical condition that would alter the absorption, distribution, metabolism or excretion of COV795
• Have a history of severe bronchial asthma, hypercarbia, or hypoxia
• Have a clinically significant abnormality on their clinical laboratory values
• Have Addison's disease, benign prostatic hyperplasia, or kidney disease
• Have donated blood or blood components within 3 months prior to the screening visit.
• Have a known allergy or hypersensitivity to any opioid analgesics, anesthetics, acetaminophen, Non-steroid anti-inflammatory drugs (NSAIDs).
• Have a history of intolerance to short term opioid use.
• Unwilling to discontinue certain prohibited medications within the allotted time before surgery and throughout the duration of the study. Have taken certain drugs within the indicated times before surgery.
• Have a history of substance or alcohol abuse and/or a positive result on drug screening.
• Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
• Have dysphagia and/or cannot swallow study medication whole.

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (5)

Trovare Clinical Research, Inc.

Bakersfield, California, 93311, 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 Trials, PA

San Antonio, Texas, 78229, United States

Location

Jean Brown Research, Inc.

Salt Lake City, Utah, 84124, United States

Location

Related Publications (2)

• Singla N, Barrett T, Sisk L, Kostenbader K, Young J. Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery. Curr Med Res Opin. 2014 Dec;30(12):2571-8. doi: 10.1185/03007995.2014.957824. Epub 2014 Oct 13.

  PMID: 25157951 DERIVED

• Singla N, Barrett T, Sisk L, Kostenbader K, Young J, Giuliani M. A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain. Curr Med Res Opin. 2014 Mar;30(3):349-59. doi: 10.1185/03007995.2013.876979. Epub 2014 Jan 10.

  PMID: 24351079 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Bunion

Interventions

oxycodone-acetaminophen

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

Results Point of Contact

• Title: Lawrence Hill
• Organization: Mallinckrodt Pharmaceuticals

lawrence.hill@mallinckrodt.com

908-238-6370

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: November 28, 2011
• First Posted: December 2, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 21, 2016
• Results First Posted: July 2, 2014

Record last verified: 2016-09

Locations

US (5)