Pain, PostoperativePhase 3NCT01743625
Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain
A Phase 3 study testing COV155 in people with Pain, Postoperative and Bunion, run by Mallinckrodt at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Bunion
- What is being tested?
- COV155
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2012to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Lotus Clinical Research, LLC
Pasadena, California, 91105
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122
Jean Brown Research, Inc.
Salt Lake City, Utah, 84124
Endeavor Clinical Trails, PA
San Antonio, Texas, 78229
About this study
Official title: 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.
- Conditions
- Pain, Postoperative, Bunion
- Being tested
- COV155, placebo
- Medical subject headings
- Pain, Postoperative, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COV155Drug
Also called MNK155
COV155 tablets
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| COV155 | Experimental | COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours. Receives: 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. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID48 (Summed pain intensity difference)
48 hour Summed pain intensity difference
Measured: 48 hours
Secondary outcomes (3)
Safety and tolerability of COV155
Safety and tolerability to be evaluated with physical exams, vital signs, pulse oximetry, clinical laboratory tests, electrocardiograms, and adverse events
Measured: 48 hours
Onset of analgesia of COV155 versus placebo
Onset of confirmed perceptible pain relief, time to meaningful pain relief, and time to peak pain intensity difference
Measured: 48 hours
Analgesic effects of COV155 versus placebo
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743625
- Sponsor's protocol ID
- COV15010232
- Status last verified
- Oct 2016
- First submitted
- 4 Dec 2012
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01743625
- Acronym / sponsor ID
- COV15010232
- Conditions
- Pain, Postoperative, Bunion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COV155 | Experimental | Drug: COV155COV155, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours. |
| Placebo | Placebo comparator | Drug: placeboMatching tablet to COV155 without containing active ingredients, loading dose of 3 tablets followed by 2 tablets every 12 hours for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COV155Also: MNK155COV155 tablets | Drug | COV155 |
| placebo | Drug | Placebo |
Primary outcome
SPID48 (Summed pain intensity difference)
Time frame: 48 hours
48 hour Summed pain intensity difference
3 secondary outcomes
Safety and tolerability of COV155
Time frame: 48 hours
Onset of analgesia of COV155 versus placebo
Time frame: 48 hours
Analgesic effects of COV155 versus placebo
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COV155 in people with Pain, Postoperative and Bunion, run by Mallinckrodt at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPID48 (Summed pain intensity difference) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.