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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT01484652
First received: November 28, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Bunion
Drug: COV795
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Safety and Analgesic Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain Followed by an Open-Label Extension

Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • SPID48 (Summed Pain Intensity Difference) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 329
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COV795 Drug: COV795
2 tablets taken every 12 hours
Other Name: MNK795
Placebo Comparator: Placebo Drug: Placebo
2 tablets taken every 12 hours

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Complete the informed consent process as documented by signed informed consent form(s).
  2. Be in generally good health.
  3. Be 18 to 75 years of age, inclusively at the time of screening.
  4. Be scheduled for a primary unilateral first metatarsal bunionectomy (with no collateral procedures).
  5. Have a body mass index ≤33 kg/m2.
  6. 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
  7. Male subjects must be sterile or commit to the use of a reliable method of birth control
  8. Be classified as Physical status 1 (PS-1) to PS-2 by the American Society of Anesthetists (ASA) Physical Status Classification System.
  9. Be willing to complete the pain evaluations and return to the clinic as scheduled.

Exclusion Criteria

  1. 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.
  2. Have a clinically significant abnormal electrocardiogram (ECG) at screening
  3. Have had any type of gastric bypass surgery or have a gastric band.
  4. Have previous abdominal surgery within the past year or history of abdominal adhesions, known or suspected paralytic ileus.
  5. Have a history of any medical condition that would alter the absorption, distribution, metabolism or excretion of COV795
  6. Have a history of severe bronchial asthma, hypercarbia, or hypoxia
  7. Have a clinically significant abnormality on their clinical laboratory values
  8. Have Addison's disease, benign prostatic hyperplasia, or kidney disease
  9. Have donated blood or blood components within 3 months prior to the screening visit.
  10. Have a known allergy or hypersensitivity to any opioid analgesics, anesthetics, acetaminophen, Non-steroid anti-inflammatory drugs (NSAIDs).
  11. Have a history of intolerance to short term opioid use.
  12. 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.
  13. Have a history of substance or alcohol abuse and/or a positive result on drug screening.
  14. Have a positive test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at the screening visit.
  15. Have dysphagia and/or cannot swallow study medication whole.
  16. Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
  17. Have previously participated in a clinical trial using COV795 or had a bunionectomy in the last 3 months.
  18. Received any investigational drugs or devices within 4 weeks prior to the screening visit.
  19. Other criteria as specified in the trial protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484652

Locations
United States, California
Trovare Clinical Research, Inc.
Bakersfield, California, United States, 93311
Lotus Clinical Research, LLC
Pasedena, California, United States, 91105
United States, Maryland
Chesapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
United States, Texas
Endeavor Clinical Trials, PA
San Antonio, Texas, United States, 78229
United States, Utah
Jean Brown Research, Inc.
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Mallinckrodt
  More Information

No publications provided by Mallinckrodt

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01484652     History of Changes
Other Study ID Numbers: COV15000182
Study First Received: November 28, 2011
Results First Received: April 11, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Moderate Post-Operative Pain
Severe Post-Operative Pain
Bunionectomy

Additional relevant MeSH terms:
Hallux Valgus
Pain, Postoperative
Foot Deformities
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 25, 2014