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Colchicine for Symptom and Inflammation in Knee Osteoarthritis

NCT02176460 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2016-04-15

No results posted yet for this study

Summary

Uric acid may be involved in the activation of the innate immune response in osteoarthritis (OA) pathology and progression. This suggests that traditional gout therapy may be beneficial for OA. Our goal therefore is to assess colchicine, an existing commercially available agent for gout, for a new therapeutic indication-knee OA. The investigators propose a randomized clinical trial (RCT) of 16 weeks' therapy with standard daily dose oral colchicine or placebo for knee OA. The investigators hypothesize that colchicine will block inflammasome mediated inflammation, thereby improve the signs and symptoms of OA, and reduce synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers. This trial will potentially provide data to support a new treatment option for knee OA.

Conditions

Interventions

DRUG

Colchicine

0.5mg twice daily for 16 weeks

DRUG

Placebo

1 tablet twice daily

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Ying Y Leung, MBChB · Singapore General Hospital

  • Virginia Kraus, MD, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Singapore

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02176460 on ClinicalTrials.gov