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

October 18, 2016 updated by: Mallinckrodt

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Evaluation of the Safety and Analgesic Efficacy of COV155 Tablets in Moderate to Severe Post-Operative Bunionectomy Pain Followed by an Open-Label Extension

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
406

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Pasadena, California, United States, 91105
        • Lotus Clinical Research, LLC
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • Chesapeake Research Group, LLC
    • Texas
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trails, PA
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COV155
COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.
Drug: COV155
COV155 tablets
Other Names:
  • MNK155
Placebo Comparator: Placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SPID48 (Summed pain intensity difference)
Time Frame: 48 hours
48 hour Summed pain intensity difference
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of COV155
Time Frame: 48 hours
Safety and tolerability to be evaluated with physical exams, vital signs, pulse oximetry, clinical laboratory tests, electrocardiograms, and adverse events
48 hours
Onset of analgesia of COV155 versus placebo
Time Frame: 48 hours
Onset of confirmed perceptible pain relief, time to meaningful pain relief, and time to peak pain intensity difference
48 hours
Analgesic effects of COV155 versus placebo
Time Frame: 48 hours
Pain intensity scores, pain intensity differences, and summed pain intensity differences; pain relief scores and total pain relief; percent responders; mean dosing interval; use of rescue medication; global assessment of subject satisfaction with study treatment.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mallinckrodt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COV15010232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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