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Knee OsteoarthritisPhase 2COMET-1NCT00521989

CRx-102 Osteoarthritis Multicenter Evaluation Trial

A Phase 2 study testing CRx-102 (2.7/90), Prednisolone and CRx-102 (2.7/180) in people with Knee Osteoarthritis, run by Zalicus at 58 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
CRx-102 (2.7/90), Prednisolone and CRx-102 (2.7/180)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
58 sitesin 2 countries
Study dates
Aug 2007to Jul 2009
Phase
Phase 2
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must voluntarily give written informed consent
  • Subject must be ≥ 40 years of age
  • Knee pain for at least 6 months requiring NSAIDs or Coxibs for analgesia on the majority of days (≥ 15 days) during the preceding month
  • WOMAC pain score when walking on a flat surface (question #1) between 30-80 mm at Screening with at least a 10 mm increase following NSAID or Coxib discontinuation during the Screening period
  • Radiographic evidence of knee OA (Kellgren-Lawrence grade 2 or 3)
  • Functional class I, II, or III according to the American Rheumatism Association
  • Subject willing to take a multivitamin or the equivalent of at least 400 IU vitamin D and the equivalent of at least 1000 mg of elemental calcium daily

Who cannot join

  • Predominant patellofemoral disease or clinically significant trauma to index knee
  • History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, osteoporotic and/or other major disease
  • History of malignancy within the past 10 years (except for excised or treated basal cell or fewer than 3 squamous cell skin carcinomas)
  • History of lymphoma or chronic leukemia
  • Moles or lesions that are currently undiagnosed, but are suspicious for malignancy
  • Surgery within the previous 3 months (except for minor dental, and/or cosmetic procedures)
Show all 35Show fewer
  • History of drug or alcohol abuse (as defined by the Investigator)
  • History of bleeding disorder
  • History of GI bleeding within 5 years of Screening
  • History of severe migraines or headaches
  • History of glaucoma
  • Visually compromising cataract
  • Active diabetic retinopathy
  • History of osteoporotic fracture
  • History of opportunistic infection
  • Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to Screening
  • Fever or symptomatic viral or bacterial infection within 2 weeks prior to Screening
  • Positive for hepatitis C (HCV) antibody
  • Positive for hepatitis B surface antigen (HBsAg)
  • Known positive history for human immunodeficiency virus (HIV) antibody
  • Surgery on the index knee within 1 year of Screening
  • History of hypersensitivity to steroids or dipyridamole
  • Treatment with oral, intramuscular, or intravenous glucocorticoids within 6 weeks prior to Screening; intra-articular glucocorticoids within 10 weeks prior to Screening; inhaled glucocorticoid is permitted
  • Treatment with injectable hyaluronic acid within 3 months of Screening
  • Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days prior to Screening
  • Treatment with NSAIDs (oral or topical), Coxibs or topical capsaicin
  • Treatment with anticoagulants including: dipyridamole, warfarin, clopidogrel, ticlopidine, or ASA > 81 mg per day
  • Treatment with any concomitant medications that have not been at a stable dose for at least 28 days prior to Screening
  • Treatment for osteoporosis such as bisphosphonates (e.g., Fosamax®, Actonel®), or teriparatide (e.g., Forteo®), or calcitonin (e.g., Miacalcin, Calcimar) must be at stable dosages for at least 3 months prior to Screening
  • ALT or AST laboratory values >1.5 X the ULN
  • HgbA1c value of >7.0%
  • Current enrollment in any other study with investigational drug or device
  • Female subject who is pregnant or lactating
  • Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
  • Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

United States57 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Bingham Farms, Michigan

  • Study site

    Bountiful, Utah

  • Study site

    Brockton, Massachusetts

  • Study site

    Chandler, Arizona

  • Study site

    Cincinnati, Ohio

  • Study site

    Covington, Louisiana

  • Study site

    Cumberland, Rhode Island

  • Study site

    Dallas, Texas

  • Study site

    Dayton, Ohio

  • Study site

    DeLand, Florida

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Eugene, Oregon

  • Study site

    Fargo, North Dakota

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Haverhill, Massachusetts

  • Study site

    Hickory, North Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Jupiter, Florida

  • Study site

    Kissimee, Florida

  • Study site

    Largo, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    Longwood, Florida

  • Study site

    Mayfield Village, Ohio

  • Study site

    Mesa, Arizona

  • Study site

    Missoula, Montana

  • Study site

    New York, New York

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Paducah, Kentucky

  • Study site

    Palm Harbor, Florida

  • Study site

    Peabody, Massachusetts

  • Study site

    Phoenix, Arizona

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plainview, New York

  • Study site

    Rancho Mirage, California

  • Study site

    Reno, Nevada

  • Study site

    Roanoke, Virginia

  • Study site

    Rochester, New York

  • Study site

    San Antonio, Texas

  • Study site

    Sandy City, Utah

  • Study site

    Sarasota, Florida

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Towson, Maryland

  • Study site

    Tuscon, Arizona

  • Study site

    Upland, California

  • Study site

    Virginia Beach, Virginia

  • Study site

    Voorhees Township, New Jersey

  • Study site

    Warwick, Rhode Island

  • Study site

    West Reading, Pennsylvania

  • Study site

    Westlake Village, California

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worcester, Massachusetts

Other trials in United States

Canada1 site

  • Study site

    Kitchener, Ontario

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis and Optional One-Year Extension

CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects.

CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA. It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.

Being tested
CRx-102 (2.7/90), Prednisolone, Placebo, CRx-102 (2.7/180), CRx-102 (2.7/360)
Keywords
Osteoarthritis, Knee, CRx-102, prednisolone, dipyridamole, CombinatoRx, WOMAC
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

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

  • CRx-102 (2.7/90)Drug

    Also called 2.7 mg prednisolone plus 90 mg dipyridamole

    CRx-102 dose 1

  • PrednisoloneDrug

    Also called 2.7 mg prednisolone

    Prednisolone

  • PlaceboDrug

    Placebo

  • CRx-102 (2.7/180)Drug

    Also called Prednisolong 2.7 mg plus dipyridamole 180 mg

    CRx-102 dose 2

  • CRx-102 (2.7/360)Drug

    Also called 2.7 mg prednisolone plus 360 mg dipyridamole

    CRx-102 dose 3

Study groups in NCT00521989
Study groupRoleWhat they receive
CRx-102 (2.7/90)Experimental2.7 mg prednisolone plus 90 mg dipyridamole Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM
Receives: Drug: CRx-102 (2.7/90)
CRx-102 (2.7/180)Experimental2.7 mg prednisolone plus 180 mg dipyridamole Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM
Receives: Drug: CRx-102 (2.7/180)
CRx-102 (2.7/360)Experimental2.7 mg prednisolone plus 360 mg dipyridamole Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM
Receives: Drug: CRx-102 (2.7/90); Drug: CRx-102 (2.7/360)
PrednisoloneActive comparator2.7 mg prednisolone Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM.
Receives: Drug: Prednisolone
PlaceboPlacebo comparatorPlacebo Subjects were dose twice daily through day 98.
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline to Day 98 Using the WOMAC Pain Question #1

    The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to "think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface." This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with "No Pain" on the left (0 mm) and "Extreme Pain" on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome.

    Measured: Baseline to Day 98

Secondary outcomes (1)

  1. To Assess the Efficacy of the CRx-102 Compared to Placebo on the Change From Baseline to Day 98 Using the Full WOMAC Pain, Stiffness, Physical Function Parameters, and Patient Global Assessment VAS.

    Measured: Day 98

Timeline

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

  1. First posted29 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJul 2009
  4. Study completionJul 2009

Why it stopped: CRx-102-006 study results, negative

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00521989
Sponsor's protocol ID
CRx-102-006
Acronym
COMET-1
Status last verified
Mar 2014
First submitted
27 Aug 2007
Last updated
29 Apr 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CRx-102 (2.7/90), Prednisolone and CRx-102 (2.7/180) in people with Knee Osteoarthritis, run by Zalicus at 58 sites in 2 countries.

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 7 inclusion and 35 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: stopped early, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Apr 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?

Change From Baseline to Day 98 Using the WOMAC Pain Question #1 (time frame: Baseline to Day 98). 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 NCT00521989.

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 29 Apr 2014.

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