Pain, PostoperativePhase 3NCT01484652

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

A Phase 3 study testing COV795 in people with Pain, Postoperative and Bunion, run by Mallinckrodt at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain, Postoperative, Bunion
What is being tested?: COV795
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 329 participants
Where: 5 sitesUnited States
Study dates: Nov 2011to Sep 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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.

Who cannot join

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

Show all 19Show fewer

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.
Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
Have previously participated in a clinical trial using COV795 or had a bunionectomy in the last 3 months.
Received any investigational drugs or devices within 4 weeks prior to the screening visit.
Other criteria as specified in the trial protocol.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Trovare Clinical Research, Inc.
Bakersfield, California, 93311
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 Trials, PA
San Antonio, Texas, 78229

Other trials in United States

About this study

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

Conditions: Pain, Postoperative, Bunion
Being tested: COV795, Placebo
Keywords: Moderate Post-Operative Pain, Severe Post-Operative Pain, Bunionectomy
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.

COV795Drug
Also called MNK795
2 tablets taken every 12 hours
PlaceboDrug
2 tablets taken every 12 hours

Study groups in NCT01484652
Study group	Role	What they receive
COV795	Experimental	Not described Receives: Drug: COV795
Placebo	Placebo comparator	Not described 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)
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.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Sep 2012

First posted2 Dec 2011 (estimated)
Study startNov 2011
Primary completionAug 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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: 329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01484652
Sponsor's protocol ID: COV15000182
Status last verified: Sep 2016
First submitted: 28 Nov 2011
Last updated: 21 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25157951
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.
PubMed 24351079

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section

All Pain, Postoperative trials

Study at a glance

From the registry record, last updated by the sponsor on 21 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 COV795 in Moderate to Severe Post-Operative Bunionectomy Pain Followed by an Open-Label Extension
ClinicalTrials.gov ID: NCT01484652
Acronym / sponsor ID: COV15000182
Conditions: Pain, Postoperative, Bunion
Keywords: Moderate Post-Operative Pain, Severe Post-Operative Pain, Bunionectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 329 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Aug 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 2 Dec 2011 (estimated)
Results: Posted 2 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
COV795	Experimental	Drug: COV795
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (19 listed)

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

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
COV795Also: MNK7952 tablets taken every 12 hours	Drug	COV795
Placebo2 tablets taken every 12 hours	Drug	Placebo

Primary outcome

SPID48 (Summed Pain Intensity Difference)
Time frame: 48 hours
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.

Results and safety

Results posted to the registry on 2 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COV795	166	151
Placebo	163	142

Primary outcome: SPID48 (Summed Pain Intensity Difference)

Time frame: 48 hours. Mean (Standard Error). Unit: scores on a scale

Measure	COV795 n = 150	Placebo n = 153
Value	114.9 (7.64)	66.9 (7.6)

Population analysed: The analysis population for the primary outcome measure was the modified intent-to-treat population (mITT). The mITT analysis population includes 303 subjects from Cohort 2. Missing pain intensity difference scores were imputed using a multiple imputation method.

Adverse events

Time frame: Serious Adverse Events (SAEs) span the entire study, ie, the double-blind and open-label extension phases. Other Adverse Events reflects data from the double-blind phase of the study.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COV795	3 of 235 (1.3%)	89 of 166 (53.6%)	Not reported
Placebo	1 of 94 (1.1%)	35 of 163 (21.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25157951Singla 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.
Derived from this study: PubMed 24351079Singla 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.

Related trials for Pain, Postoperative

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section

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 COV795 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 9 inclusion and 19 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 21 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?

Yes. Results are posted in the registry (first posted 2 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

On the ClinicalTrials.gov record for NCT01484652, which also lists 2 linked publications.

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 21 Oct 2016.