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Nonsteroidal Anti-inflammatory Drug (NSAID)

Diacerein for Osteoarthritis (DISSCO Trial)

Phase 3
Waitlist Available
Led By Jean-Pierre Pelletier, MD, FRCPC
Research Sponsored by TRB Chemedica International SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 728 days
Awards & highlights

Summary

Osteoarthritis (OA) of the knee is the most frequent cause of knee pain after the age of 50 years. OA is a joint disease characterised by articular cartilage loss associated with structural changes in the cartilage and adjacent structures. The main symptoms are pain and functional disability. The goals of OA therapy are to decrease pain and maintain or improve joint function. There is evidence that diacerein has both a symptomatic and a structural effect on cartilage, and clinical studies suggest that diacerein therapy significantly decreases OA symptoms when compared to placebo. Diacerein has been shown to inhibit interleukine-1 (IL-1β), and down-regulated IL-1β stimulated secretion of metalloproteinases and aggrecanases, and thereby prevent breakdown of cartilage by these enzymes. Diacerein has no effect on the synthesis of prostaglandins, and therefore no effect on the upper intestinal tract. The purpose of this phase III-IV international, multicentre, double-blind, non-inferiority, randomised, controlled study is to determine the efficacy and safety of diacerein vs. celecoxib on symptoms after 6 months of treatment, and on structural changes after 2 years of treatment in knee OA patients as assessed by magnetic resonance imaging (MRI).

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 728 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 728 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change Form Baseline in WOMAC A Pain Subscale
Secondary outcome measures
Absolute Changes From Baseline in Pain Visual Analogue Scale
Assessment of Joint Swelling, Effusion or Both
Change From Baseline in Patient's Global Assessment of Disease Activity
+5 more
Other outcome measures
Cartilage Volume Loss From Baseline in the Lateral Compartment Using MRI
Cartilage Volume Loss From Baseline in the Medial Compartment Using MRI
Change From Baseline in Global Stiffness Using WOMAC Subscale
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DiacereinExperimental Treatment2 Interventions
One placebo capsule once daily in the morning (breakfast) and one diacerein 50 mg capsule once daily in the evening (dinner) for the first month, then diacerein capsules twice daily with meals in the morning (breakfast) and the evening (dinner).
Group II: CelecoxibActive Control2 Interventions
One celecoxib 200 mg capsule once daily in the morning (breakfast) and one placebo capsule once daily in the evening (dinner).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Diacerein
FDA approved

Find a Location

Who is running the clinical trial?

TRB Chemedica International SALead Sponsor
2 Previous Clinical Trials
160 Total Patients Enrolled
ArthroLab Inc.Industry Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Osteoarthritis
50 Patients Enrolled for Osteoarthritis
Jean-Pierre Pelletier, MD, FRCPCPrincipal InvestigatorArthroLab Inc.
~41 spots leftby Jul 2025