- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01743625
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
406
Phase
- 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
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California
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Anaheim, California, United States, 92801
- Anaheim Clinical Trials
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Pasadena, California, United States, 91105
- Lotus Clinical Research, LLC
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Maryland
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Pasadena, Maryland, United States, 21122
- Chesapeake Research Group, Llc
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Texas
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San Antonio, Texas, United States, 78229
- Endeavor Clinical Trails, PA
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Utah
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Salt Lake City, Utah, United States, 84124
- Jean Brown Research, Inc.
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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
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 |
Intervention / Treatment |
---|---|
Experimental: COV155
COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours.
|
COV155 tablets
Other Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SPID48 (Summed pain intensity difference)
Time Frame: 48 hours
|
48 hour Summed pain intensity difference
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48 hours
|
Secondary Outcome Measures
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
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48 hours
|
Onset of analgesia of COV155 versus placebo
Time Frame: 48 hours
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Onset of confirmed perceptible pain relief, time to meaningful pain relief, and time to peak pain intensity difference
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48 hours
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Analgesic effects of COV155 versus placebo
Time Frame: 48 hours
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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.
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48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
December 4, 2012
First Submitted That Met QC Criteria
December 5, 2012
First Posted (Estimate)
December 6, 2012
Study Record Updates
Last Update Posted (Estimate)
October 19, 2016
Last Update Submitted That Met QC Criteria
October 18, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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