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CRx-102 Osteoarthritis Multicenter Evaluation Trial

NCT00521989 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2014-04-29

Study results available
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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 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.

Conditions

Interventions

DRUG

CRx-102 (2.7/90)

CRx-102 dose 1

DRUG

Prednisolone

Prednisolone

DRUG

Placebo

Placebo

DRUG

CRx-102 (2.7/180)

CRx-102 dose 2

DRUG

CRx-102 (2.7/360)

CRx-102 dose 3

Sponsors & Collaborators

  • Zalicus

    lead INDUSTRY

Principal Investigators

  • Margaret Lee, PhD · Zalicus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00521989 on ClinicalTrials.gov