OsteoarthritisPhase 3NCT01451385

Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain

A Phase 3 study testing COV795 in people with Osteoarthritis and Low Back Pain, run by Mallinckrodt at 42 sites in United States.

Completed

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

Official record

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Trial summary

The primary objective is to demonstrate the safety and tolerability of COV795 with up to 35 days use as evaluated by physical exam, vital signs, pulse oximetry, clinical laboratory tests, and other adverse events (AEs). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Low Back Pain
What is being tested?: COV795
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 376 participants
Where: 42 sitesUnited States
Study dates: 20 Sep 2011to 18 Jun 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be considered in general good health based upon medical and surgical history, vital signs, pulse oximetry, physical exam, clinical lab tests, and electrocardiogram (ECG).
Be ≥18 years of age
Female subjects are eligible if not pregnant, not lactating or not planning to become pregnant within the next 2 months; surgically sterile or at least 2 years postmenopausal, or practicing an acceptable form of birth control for the duration of the study
Male subjects biologically capable of having children must agree to the use of a reliable method of birth control for the duration of the study
Have a clinical diagnosis of one of the following:
Osteoarthritis (OA) of the knee or hip for at least one year based on the American College of Rheumatology (ACR) criteria

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Moderate to severe chronic lower back pain (CLBP), i.e. pain that occurs in an area with boundaries between the lowest rib and the crease of the buttocks that 1) must have been present for at least several hours a day for a minimum of 3 months, 2) is not due to a known malignancy, and 3) must be classified as non-neuropathic, neuropathic, or symptomatic for more than 6 months after lower back pain (LBP) surgery based on the Quebec Task Force Classification of Spinal Disorders
Have an average in-clinic pain score of ≥3 on the 11-point (0-10) numerical rating scale (NRS) as an average for the last 24 hours at screening visit.
Have a pain intensity score of ≥4 on NRS as an average for the last 24 hours at baseline visit.
Must, in the investigator's opinion, qualify for opioid therapy for their CLBP or OA.
Voluntarily provide written informed consent.

Who cannot join

Have any clinically significant condition or unstable inter-current illness that would preclude study participation or interfere with the assessment of pain and other symptoms of CLBP or OA or would increase the risk of opioid-related AEs
Have an uncontrolled or poorly controlled major psychiatric condition, or have clinically significant anxiety or depression
Have an active malignancy or history of malignancy within 2 years
Have a history of seizures (except pediatric febrile seizures) or cognitive dysfunction
Have clinically significant ECG abnormalities or have uncontrolled hypo- or hypertension
Had arthroscopic or open surgery on either knee or hip selected as the primary OA study joint within 6 months

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For CLBP, had a surgical procedure for back pain within 6 months
For CLBP participants, had a nerve or plexus block within 1 month or botulinum toxin injection in the lower back region within 3 months. For participants with OA of the selected primary joint, had joint injection within 1 month prior to Screening Visit 1.
Had surgical implants of either the knee or hip selected as the primary OA joint
Had gastric reduction surgery
Have been taking opioids in equivalents to more than 20 mg oxycodone hydrochloride (OC) or more than 40 mg morphine sulfate (MS) orally per day, or have been taking opioid medications 4 times a week or more
Unable to discontinue use of prohibited medications
Have a known allergy or hypersensitivity to opioids, OC, acetaminophen (APAP) or ibuprofen.
Have abnormal clinical laboratory tests at screening
Have a history of substance or alcohol abuse
Have positive screening labs for human immunodeficiency virus (HIV), Hepatitis B and/or Hepatitis C
Have a positive urine drug test for alcohol, illicit drugs, or controlled substances other than those prescribed medications
Have previously participated in a clinical trial using COV795
Received any investigational drugs or devices in the past 4 weeks
History of spinal stenosis
Other criteria as specified in the trial protocol

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

Allegheny Pain Management
Altoona, Pennsylvania, 16602
Advanced Clinical Research Institute
Anaheim, California, 92801
Orange County Research Institute
Anaheim, California, 92801
United Clinical Research Center, Inc.
Anaheim, California, 92804
FutureSearch Trials
Austin, Texas, 78731
Austin Diagnostic Clinic
Austin, Texas, 78758
QUEST Research Institute
Bingham Farms, Michigan, 48025
Orthopedic Research Institute
Boynton Beach, Florida, 33472
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620
Chicago Anesthesia Pain Specialists
Chicago, Illinois, 60657
Catalina Research Institute, LLC
Chino, California, 91710
Hightop Medical Research Center/Hilltop Physicians Inc.
Cincinnati, Ohio, 45224
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Community Research
Cincinnati, Ohio, 45245
Community Research
Crestview Hills, Kentucky, 41017
KRK Medical Research
Dallas, Texas, 75230
Avail Clinical Research
DeLand, Florida, 32720
Synergy Escondido Clinical Research
Escondido, California, 92025
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Convergys Clinical Research, Inc.
Fresno, California, 93726
Eastern Research
Hialeah, Florida, 33013
Peters Medical Research
High Point, North Carolina, 27262
Triwest Research Associates
La Mesa, California, 91942
International Clinical Research Institute
Leawood, Kansas, 66211
Skyline Research, Inc.
Long Beach, California, 90806
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431
Drug Studies America
Marietta, Georgia, 30060
Better Health Clinical Research
Newnan, Georgia, 30265
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
Quality Clinical Research
Omaha, Nebraska, 68114
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Compass Research, LLC
Orlando, Florida, 32806
Compass Research East, LLC
Oviedo, Florida, 32765
Gold Coast Research LLC
Plantation, Florida, 33317
Accord Clinical Research, LLC
Port Orange, Florida, 32129
Optimum Clinical Research, Inc.
Salt Lake City, Utah, 84102
Sarasota Pain Medicine Research, LLC
Sarasota, Florida, 34238
Sundance Clinical Research
St Louis, Missouri, 63141
Stedman Clinical Trials
Tampa, Florida, 33613
Premier Research
Trenton, New Jersey, 08540
Genova Clinical Research
Tucson, Arizona, 85704
The Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain

Conditions: Osteoarthritis, Low Back Pain
Being tested: COV795
Medical subject headings: Osteoarthritis, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COV795Drug
Also called MNK795
COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)

Study groups in NCT01451385
Study group	Role	What they receive
COV795	Experimental	Participants receive 2 tablets of COV795 every 12 hours for up to 35 days Receives: Drug: COV795

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Adverse Events (AEs)
Collection of AEs began with subject's signing of the informed consent form, continued throughout the trial, and ended 7 days following the last dose of study drug, or at early termination. Treatment emergent AEs (TEAEs) are AEs that occurred after the first dose of study drug. TEAEs leading to discontinuation include 2 subjects who died (deaths not related to study drug). Clinically significant changes in values from physical exam, vital signs, clinical laboratory tests, and pulse oximetry were included as treatment emergent adverse events (TEAEs).
Measured: 5 Weeks

Secondary outcomes (8)

Modified Brief Pain Index - Short Form: Pain Intensity
Participants rate their pain on a score from 0=no pain to 10=pain as bad as you can imagine
Measured: at end of treatment (within 5 weeks)
Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication
Participants rate percent pain relief from medication on a scale from 0% (no relief) to 100% (complete relief)
Measured: at end of treatment (within 5 weeks)
Modified Brief Pain Inventory-Short Form: Pain Interference Scores
Participants answer several questions about how much the pain interferes with their quality of life. The answers range from 0 = no interference to 10=completely interferes, and the average score for all the questions is recorded.
Measured: at end of treatment (within 5 weeks)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC pain score ranges from 0 to 20, with higher scores representing worse pain.
Measured: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC stiffness score ranges from 0 to 8, with higher scores representing worse stiffness.
Measured: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function Score
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC physical function score ranges from 0 to 68, with higher scores representing worse functional limitations.
Measured: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score
Disease-specific quality of life is assessed using the WOMAC questionnaire (48-hour version) for participants with osteoarthritis (OA) of the hip or knee. The WOMAC total score ranges from 0 to 96, with higher scores representing worse pain/disability.
Measured: End of treatment (within 5 weeks)
Roland-Morris Low Back Pain and Disability Scores for Participants With Chronic Low Back Pain
Roland-Morris Low Back Pain and Disability Scores for participants with chronic low back pain range from 0 to 24, with higher scores representing greater disability.
Measured: End of treatment (within 5 weeks)

Timeline

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

20 Sep 201118 Jun 2012

First posted13 Oct 2011 (estimated)
Study start20 Sep 2011
Primary completion18 Jun 2012
Study completion18 Jun 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.
Other trials for OsteoarthritisStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 376 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01451385
Sponsor's protocol ID: COV15000181
Status last verified: Sep 2020
First submitted: 29 Sep 2011
Last updated: 18 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Safety Study of COV795 in Subjects With Osteoarthritis or Chronic Low Back Pain
ClinicalTrials.gov ID: NCT01451385
Acronym / sponsor ID: COV15000181
Conditions: Osteoarthritis, Low Back Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 376 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: 20 Sep 2011
Primary completion: 18 Jun 2012 (actual)
Study completion: 18 Jun 2012 (actual)
First posted: 13 Oct 2011 (estimated)
Results: Posted 17 Sep 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
COV795	Experimental	Drug: COV795Participants receive 2 tablets of COV795 every 12 hours for up to 35 days

Who may qualify

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

Key inclusion criteria (11 listed)

Be considered in general good health based upon medical and surgical history, vital signs, pulse oximetry, physical exam, clinical lab tests, and electrocardiogram (ECG).
Be ≥18 years of age
Female subjects are eligible if not pregnant, not lactating or not planning to become pregnant within the next 2 months; surgically sterile or at least 2 years postmenopausal, or practicing an acceptable form of birth control for the duration of the study
Male subjects biologically capable of having children must agree to the use of a reliable method of birth control for the duration of the study
Have a clinical diagnosis of one of the following:

Key exclusion criteria (21 listed)

Have any clinically significant condition or unstable inter-current illness that would preclude study participation or interfere with the assessment of pain and other symptoms of CLBP or OA or would increase the risk of opioid-related AEs
Have an uncontrolled or poorly controlled major psychiatric condition, or have clinically significant anxiety or depression
Have an active malignancy or history of malignancy within 2 years
Have a history of seizures (except pediatric febrile seizures) or cognitive dysfunction
Have clinically significant ECG abnormalities or have uncontrolled hypo- or hypertension

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: MNK795COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)	Drug	COV795

Primary outcome

Summary of Adverse Events (AEs)
Time frame: 5 Weeks
Collection of AEs began with subject's signing of the informed consent form, continued throughout the trial, and ended 7 days following the last dose of study drug, or at early termination. Treatment emergent AEs (TEAEs) are AEs that occurred after the first dose of study drug. TEAEs leading to discontinuation include 2 subjects who died (deaths not related to study drug). Clinically significant changes in values from physical exam, vital signs, clinical laboratory tests, and pulse oximetry were included as treatment emergent adverse events (TEAEs).

8 secondary outcomes

Modified Brief Pain Index - Short Form: Pain Intensity
Time frame: at end of treatment (within 5 weeks)
Modified Brief Pain Index - Short Form: Percent Pain Relief From Medication
Time frame: at end of treatment (within 5 weeks)
Modified Brief Pain Inventory-Short Form: Pain Interference Scores
Time frame: at end of treatment (within 5 weeks)
Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Pain Score
Time frame: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Stiffness Score
Time frame: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Physical Function Score
Time frame: End of treatment (within 5 weeks)
WOMAC Questionnaire for Participants With Osteoarthritis (OA) of the Hip or Knee: Total Score
Time frame: End of treatment (within 5 weeks)
Roland-Morris Low Back Pain and Disability Scores for Participants With Chronic Low Back Pain
Time frame: End of treatment (within 5 weeks)

Results and safety

Results posted to the registry on 17 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	376	285

Primary outcome: Summary of Adverse Events (AEs)

Time frame: 5 Weeks. Count of participants. Unit: Participants

Measure	All Participants n = 376
Had any TEAE	235
Had a Severe TEAE	17
Had a TEAE related to study medication	200
Had a Serious AE	4
Died	2
Had a TEAE leading to discontinuation	73

Population analysed: All participants = safety population

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening to follow-up, up to 45 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	4 of 376 (1.1%)	235 of 376 (62.5%)	2 of 376

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis

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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.

42 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 Osteoarthritis and Low Back Pain, run by Mallinckrodt at 42 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 11 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 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. 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 17 Sep 2020). 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?

Summary of Adverse Events (AEs) (time frame: 5 Weeks). 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 NCT01451385.

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 18 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.