CRx-102 Osteoarthritis Multicenter Evaluation Trial

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00521989

Run by

Zalicus

People needed

279

Starts

2007-08-01

Expected to finish

2009-07-01

Last updated by the study team

2014-04-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• 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

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tuscon, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Upland, California, United States
• Study site — Westlake Village, California, United States
• Study site — DeLand, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Kissimee, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Paducah, Kentucky, United States
• Study site — Covington, Louisiana, United States
• Study site — Towson, Maryland, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Haverhill, Massachusetts, United States
• Study site — Peabody, Massachusetts, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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