NCT02688400: DISSCO

An International, Multicentre, Double-blind, Randomised Study of the Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis Patients as Assessed by Magnetic Resonance Imaging

Completed Phase 3 Results posted Last updated 29 November 2023

What this trial tests

Phase 3 trial testing Diacerein in Osteoarthritis in 380 participants. Completed in 28 June 2018.

Timeline

1 May 2016

Primary endpoint
26 June 2018

28 June 2018

Quick facts

Lead sponsor	TRB Chemedica International SA
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	380
Start date	1 May 2016
Primary completion	26 June 2018
Estimated completion	28 June 2018
Sites	22 locations across Austria, Belgium, Canada, Czechia, Spain

Drugs / interventions tested

• Diacerein (DIACEREIN) — full drug profile →
• Celecoxib (celecoxib) — full drug profile →
• Placebo

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →
• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

TRB Chemedica International SA

Who can join

50 and older, any sex, with Osteoarthritis or Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change Form Baseline in WOMAC A Pain Subscale
  Time frame: baseline and 182 days
  Change form baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) A pain subscale after 182 days of treatment. WOMAC A pain subscale: 0 - 50 cm; 50 = worse

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Development of Disease-Modifying Therapies for Osteoarthritis (DMOADs): The Evidence to Date.
   Oo WM, Little C, Duong V, Hunter DJ. · · 2021 · cited 147× · PMID 34262259 · DOI 10.2147/dddt.s295224
2. Repurposed and investigational disease-modifying drugs in osteoarthritis (DMOADs).
   Oo WM, Hunter DJ, Hunter DJ. · · 2022 · cited 38× · PMID 35619876 · DOI 10.1177/1759720x221090297
3. An international, multicentre, double-blind, randomized study (DISSCO): effect of diacerein vs celecoxib on symptoms in knee osteoarthritis.
   Pelletier JP, Raynauld JP, Dorais M, Bessette L, et al · · 2020 · cited 26× · PMID 32521015 · DOI 10.1093/rheumatology/keaa072
4. Latest insights in disease-modifying osteoarthritis drugs development.
   Li S, Cao P, Chen T, Ding C. · · 2023 · cited 24× · PMID 37197024 · DOI 10.1177/1759720x231169839
5. Challenges and opportunities of pharmacological interventions for osteoarthritis: A review of current clinical trials and developments.
   Vrouwe JPM, Burggraaf J, Kloppenburg M, Stuurman FE. · · 2021 · cited 16× · PMID 36474768 · DOI 10.1016/j.ocarto.2021.100212
6. Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
   Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8
7. Advances in Drug Delivery Science for Diacerein: Strategies to Enhance Solubility, Bioavailability, and Pharmacokinetic Performance.
   Naseri M, Ghobakhlou S, Heidarizade N, Akbari ME, et al · · 2025 · PMID 41471053 · DOI 10.3390/pharmaceutics17121539