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OsteoarthritisPhase 3DISSCONCT02688400

Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis

A Phase 3 study testing Diacerein and Celecoxib in people with Osteoarthritis and Osteoarthritis, Knee, run by TRB Chemedica International SA at 22 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoarthritis, Osteoarthritis, Knee
What is being tested?
Diacerein and Celecoxib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
22 sitesin 5 countries
Study dates
May 2016to 28 Jun 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women of at least 50 years of age;
  • Patients followed in an ambulatory clinic;
  • Patients presenting primary OA of the knee according to American College or Rheumatology (ACR) criteria;
  • Patients with OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
  • Patients with a minimum joint space width ≥ 2 mm in the medial tibio-femoral compartment on standing knee X-ray (MRI structural study only);
  • Patients with knee pain on most days of the month before entering into the study;
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  • Patients with a VAS pain score (0-100 mm) while walking on a flat surface ≥ 40 mm (Visit 1 (Screening) and Visit 2 (Inclusion Visits));
  • Patients with no clinically significant laboratory abnormalities in the judgment of the investigator;
  • Female patients who are postmenopausal with confirmed amenorrhea for at least one year before entering this study and those who underwent tubal ligation, oophorectomy or hysterectomy must agree to a hormonal (folliculo-stimulating hormone [FSH]) dosage at Screening visit ;
  • Patients agreeing to sign the Informed Consent Form prior to any study-related activities after having been clearly informed of its methods and constraints;
  • Patients not taking part in another clinical study;
  • Patients agreeing to respect the protocol by attending the visits related to the study.

Who cannot join

  • Criteria related to individual characteristics of the patient
  • Patients with secondary knee OA;
  • Patients with known hypersensitivity to Diacerein or to anthraquinone-containing product, hypersensitivity to Celecoxib, who have demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid [ASA]), lactose, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen or paracetamol;
  • Patients with a known history of diarrhoea, more particularly if 65 years of age and older;
  • Patients with active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma;
  • Patients with other bone and articular diseases (antecedents and/or current signs) such as; chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease;
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  • Pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint;
  • Patients with fibromyalgia;
  • Patients with isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only;
  • Patients with Class IV functional capacity using the American Rheumatism Association criteria;
  • Patients who have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Inclusion Visit (Visit 2);
  • Patients who have had meniscal surgery on the study knee;
  • Patients who have undergone total knee replacement in the contralateral knee within 180 days prior to the Screening Visit (Visit 1);
  • Patients with co-morbid conditions or joint deformity that restrict knee function;
  • Patients with a history of heart attack or stroke, or who have had serious diseases of the heart such as congestive heart failure (functional classes II-IV of the New York Heart Association [NYHA]);
  • Patients who have significant risk factors for heart attack or stroke will be assessed carefully. Risk factors for heart attack and stroke include high blood pressure (treated or untreated), high cholesterol, diabetes and smoking. The global risk assessment will be assessed using the American Heart Association (AHA) assessment of cardiovascular (CV) risk tables. Patients with high risk of CV events, according to the tables, will be excluded;
  • Patients with any significant diseases or conditions, including emotional or psychiatric disorders and substance abuse that, in the opinion of the Investigator, are likely to alter appreciation of OA symptoms or the patient's ability to complete the study;
  • Patients with a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the patient;
  • Patients with poorly controlled diabetes mellitus defined as Haemoglobin A1c level >8%;
  • Patients with poorly controlled hypertension (sustained Systolic Blood Pressure of > 150 mmHg or Diastolic Blood Pressure > 95 mmHg);
  • Patients with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections;
  • Patients with a history of recurrent upper gastrointestinal (UGI) ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other condition, which in the Investigator's opinion might preclude the chronic use of Celecoxib or Diacerein. Patients may, at the Investigator's discretion, take a proton pump inhibitor (PPI) or antacids daily as required, with a 2 hour period between intake of study medication and intake of PPI or antacid;
  • Patients who have been diagnosed as having or have been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication;
  • Patients with chronic liver or kidney disease, as defined by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine > 2.0 times ULN, at the Screening Visit (Visit 1);
  • Patients who have a history of intolerance to acetaminophen or paracetamol, opioids or opioid combinations such that it is felt that an adequate non-anti-inflammatory rescue analgesic regimen cannot be safely prescribed;
  • Patients who have a history of alcohol or substance abuse within the last 3 years;
  • Patients receiving any investigational drug within 30 days or 5 half-lives (whichever is greater) prior to the Inclusion Visit (Visit 2);
  • Patients who plan surgery during the study;
  • Female patients who are breastfeeding;
  • Patients with the impossibility of taking part in the total duration of the study and attending the visits;
  • Patients unable to give an informed consent;
  • Patients who do not respect the acetaminophen or paracetamol washout period of 48 hours or the NSAID washout period of 1 week before the Inclusion Visit (Visit 2).
  • Treatment-Related Exclusion:
  • Patients using corticosteroids (oral, injectable; exception of intraarticular/soft tissue injection at the exclusion of the target knee), indomethacin, therapeutic dose of glucosamine, chondroitin sulphate or Diacerein or Avocado-Soybean Unsaponifiables (ASU) during the 12 weeks preceding inclusion (intraarticular injections of corticosteroids in the contralateral knee is allowed during the study);
  • Patients using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion;
  • Patients using natural health products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding inclusion;
  • Patients using natural health products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding inclusion;
  • Patients receiving radioactive synovectomy (target knee) during the 12 weeks preceding inclusion;
  • Patients who are taking NSAIDs and do not want to stop during the study;
  • If treatment of osteoporosis (bisphosphonates, selective estrogen receptor modulators [SERMS], thyroid-stimulating hormone [TSH]) is necessary, it will have to be continued, unmodified, for the entire duration of the study;
  • Patients who have used compounds containing non-approved agents for arthritis or agents claiming to possess disease/structure-modifying properties in the 14 days prior to the Inclusion Visit (Visit 2);
  • Patients who have used medications with matrix metalloproteinase (MMP)-inhibitory properties (e.g. tetracycline or structurally related compounds) within 28 days prior to the Inclusion Visit (Visit 2);
  • Patients who require acetaminophen or paracetamol at daily doses > 2000 mg (2g) on a regular basis;
  • Patients who are taking a laxative, lithium carbonate, phenytoin or anticoagulants (with the exception of ASA up to a maximum daily dose of 325 mg);
  • Patients who have received chondrocyte transplants or underwent other type of cartilage repair procedures in the target joint;
  • Patients who use oral or topical coxibs;
  • Patients who use calcitonin;
  • Patients who use immunosuppressive drugs.
  • Criteria-Related to Magnetic Resonance Imaging (MRI):
  • Patients presenting a counter-indication to an MRI examination;
  • Patients whose Inclusion Visit cartilage volume cannot be calculated from the MRI due to advanced OA disease;
  • Patients whose Inclusion Visit cartilage volume cannot be calculated from the MRI due to the presence of large fat pads or any other technical reason;
  • Patients with study knee not entering in the MRI magnet;
  • Patients with abnormal Inclusion Visit findings and/or any other condition, which, in the Investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data through MRI to achieve the objectives of the study.

Trial locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

Canada8 sites

  • Institut de recherche en rhumatologie de Montréal

    Montreal, Quebec, H2L1S6

  • PPS Medical Inc

    Montreal, Quebec, H3T1Y3

  • Hopital du Sacré Coeur de Montréal du CIUSS du Nord-de-l'île-de-Montréal

    Montreal, Quebec, H4J 1C5

  • West Island Rheumatology Research Associates

    Pointe-Claire, Quebec, H9R3J1

  • Diex Recherche Québec Inc.

    Québec, Quebec, G1N 4V3

  • G.R.M.O (Groupe de recherche en rhumatologie et maladies osseuses) Inc.

    Québec, G1V3M7

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1H1Z1

  • Centre de recherche musculo-squelettique

    Trois-Rivières, Quebec, G8Z1Y2

Other trials in Canada

Spain7 sites

  • Rheumatology Hospital Universitario A Coruna

    A Coruña, 15009

  • Rheumatology Instituto Poal de Reumatologia

    Barcelona, 08022

  • Rheumatology Bellvitge University Hospital

    Barcelona, 08907

  • Hospital Quiron, Unidad de Medicina interna

    Barcelona

  • Rheumatology Hospital del Mar - Parc de Salut Mar

    Barcelona

  • Universitario de Mostoles Río Júcar

    Madrid, 28935

  • Departament de Reumatologia Hospital Parc Tauli de Sabadell

    Sabadell

Other trials in Spain

Czechia4 sites

  • Rheumatology St. Anne's University Hospital Brno

    Brno, 638 00

  • Institute of Rheumatology and Clinic of Rheumatology Charles University

    Prague, 128 50

  • Affidea Praha, s.r.o.

    Prague

  • Medical Plus s.r.o.

    Uherské Hradiště

Other trials in Czechia

Belgium2 sites

  • Institut Médical Spécialisé - Centre DISCCA

    Hornu

  • Reumatologie Medizorg Merksem

    Merksem

Other trials in Belgium

Austria1 site

  • State Hospital Stockerau Karl Landsteiner Institute for Clinical Rheumatology

    Stockerau

Other trials in Austria

About this study

Official title: 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

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).

Read the detailed description

The study was a phase III (Canada and Belgium) or IV (Spain, Austria and Czech Republic) international, multicentre, double-blind, randomized, controlled, parallel-groups, symptom-modifying and structure-modifying clinical study of Diacerein (50 mg twice daily) versus Celecoxib (200 mg once daily).

It was planned that 400 patients (males and females) of at least 50 years of age would take part in the study (approximately 150 patients in Canada and 250 patients in European countries). All patients were included after a Screening Visit (washout of previous medication for osteoarthritis) and randomized at the Inclusion Visit (Day 0) in 2 treatment groups of 200 patients as follows:

  • Diacerein arm: one 50 mg capsule taken once a day for one month and 50 mg twice daily thereafter (n = 200 patients),
  • Celecoxib arm: one 200 mg capsule once daily (n = 200 patients). All patients were assessed at Screening Visit (Visit 1), Inclusion (Visit 2, Day 0), Visit 3 (Day 60), Visit 4 (Day 120) and Visit 5 (Day 182 / early termination) (symptom study).

The duration of the double-blind study for each patient was up to 182 ± 7 days for the symptom study.

During the study, patients were allowed to take acetaminophen 500 mg, to a maximum of 2 g per day, dispensed at each visit by the investigator for rescue therapy.

Pain and other functional symptoms were primary analysed after 6 months (182 days) of treatment (symptom study).

Acetaminophen was dispensed during the study as rescue therapy in case of pain. However, it was asked to discontinue acetaminophen 48 hours before each study procedure/assessment of efficacy.

Being tested
Diacerein, Celecoxib, Placebo
Keywords
Osteoarthritis, Knee, Osteoarthritis, Knee, Diacerein, Celecoxib, Phase III, Phase IV, Phase III-IV, Canada, Spain, Austria, Czech Republic, WOMAC
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiacereinDrug

    Also called Artrodar, Artrodarin, Artrolyt, Fisiodar, Galaxdar, Glizolan, Verboril

  • CelecoxibDrug

    Also called Celebrex

  • PlaceboDrug

Study groups in NCT02688400
Study groupRoleWhat they receive
DiacereinExperimentalOne 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).
Receives: Drug: Diacerein; Drug: Placebo
CelecoxibActive comparatorOne celecoxib 200 mg capsule once daily in the morning (breakfast) and one placebo capsule once daily in the evening (dinner).
Receives: Drug: Celecoxib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change Form Baseline in WOMAC A Pain Subscale

    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

    Measured: baseline and 182 days

Secondary outcomes (8)

  1. Change From Baseline in WOMAC OA Scores

    Absolute Changes from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) after 182 days of treatment.

    WOMAC scale: 0 - 240 cm; 240 = worse - Intention-To-Treat (N=370) Pain subscale: 0-50cm; 50 = worse; Stifness subscale: 0-20cm; 20 = worse; Function subscale: 0-170cm; 170 = worse Absolute changes in WOMAC scores: <0 = improvement; 0 = stable; >0 = worsening

    Measured: Day 182 or early termination

  2. Absolute Changes From Baseline in Pain Visual Analogue Scale

    Absolute Changes from Baseline in Pain Visual Analogue Scale (VAS): 0-10 cm; 10 = worse

    Measured: Day 182 or early termination

  3. OARSI Responders

    Osteoarthritis Research Society International (OARSI) Responders

    Measured: Day 182 or early termination

  4. Assessment of Joint Swelling, Effusion or Both

    Assessment of Joint Swelling, joint Effusion or Both

    Measured: Day 182 or early termination

  5. Consumption of Acetaminophen

    Overall Daily number of tablets taken during the 6 month study

    Measured: Day 182 or early termination

  6. Change From Baseline in Patient's Global Assessment of Disease Activity

    Change from baseline in global assessment of disease activity was assessed using a VAS scale (0-10cm; 10=worse)

    Measured: Day 182 or early termination

  7. Global Assessment of Response to Therapy

    Between group comparison in Patient's and Investigator's Global Assessment of Response to Therapy using a 0-10 cm disease activity VAS scale: 0 cm = very well; 10 cm = very poorly

    Measured: Day 182 or early termination

  8. Quality of Life SF-36

    Absolute Changes from Baseline in Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the Quality of Life questionnaire SF-36. Scale range for each component (PCS and MCS): minimum = 0, maximum = 100, with higher scores indicating better quality of life. Absolute changes in each component (PCS and MCS): >0 = improvement; 0 = stable; <0 = worsening.

    Measured: Day 182 or early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion26 Jun 2018
  4. Study completion28 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02688400
Sponsor's protocol ID
DAR-INT-14-01
Other IDs
2015-002933-23, 2015
Acronym
DISSCO
Status last verified
Nov 2023
First submitted
10 Feb 2016
Last updated
1 Dec 2023
Data monitoring committee
Yes

Publications

  • Pavelka K, Trc T, Karpas K, Vitek P, Sedlackova M, Vlasakova V, Bohmova J, Rovensky J. The efficacy and safety of diacerein in the treatment of painful osteoarthritis of the knee: a randomized, multicenter, double-blind, placebo-controlled study with primary end points at two months after the end of a three-month treatment period. Arthritis Rheum. 2007 Dec;56(12):4055-64. doi: 10.1002/art.23056.

    PubMed 18050202

  • Bartels EM, Bliddal H, Schondorff PK, Altman RD, Zhang W, Christensen R. Symptomatic efficacy and safety of diacerein in the treatment of osteoarthritis: a meta-analysis of randomized placebo-controlled trials. Osteoarthritis Cartilage. 2010 Mar;18(3):289-96. doi: 10.1016/j.joca.2009.10.006. Epub 2009 Oct 14.

    PubMed 19857509

  • Moldovan F, Pelletier JP, Jolicoeur FC, Cloutier JM, Martel-Pelletier J. Diacerhein and rhein reduce the ICE-induced IL-1beta and IL-18 activation in human osteoarthritic cartilage. Osteoarthritis Cartilage. 2000 May;8(3):186-96. doi: 10.1053/joca.1999.0289.

    PubMed 10806046

  • Pelletier JP, Mineau F, Fernandes JC, Duval N, Martel-Pelletier J. Diacerhein and rhein reduce the interleukin 1beta stimulated inducible nitric oxide synthesis level and activity while stimulating cyclooxygenase-2 synthesis in human osteoarthritic chondrocytes. J Rheumatol. 1998 Dec;25(12):2417-24.

    PubMed 9858439

  • Martel-Pelletier J, Mineau F, Jolicoeur FC, Cloutier JM, Pelletier JP. In vitro effects of diacerhein and rhein on interleukin 1 and tumor necrosis factor-alpha systems in human osteoarthritic synovium and chondrocytes. J Rheumatol. 1998 Apr;25(4):753-62.

    PubMed 9558181

  • Franchi-Micheli S, Lavacchi L, Friedmann CA, Zilletti L. The influence of rhein on the biosynthesis of prostaglandin-like substances in-vitro. J Pharm Pharmacol. 1983 Apr;35(4):262-4. doi: 10.1111/j.2042-7158.1983.tb02929.x. No abstract available.

    PubMed 6133942

  • Petrillo M, Montrone F, Ardizzone S, Caruso I, Porro GB. Endoscopic evaluation of diacetylrhein-induced gastric-mucosal lesions. Curr Ther Res Clin Exp. 1991;49(1):10-15.

  • Pelletier JP, Raynauld JP, Dorais M, Bessette L, Dokoupilova E, Morin F, Pavelka K, Paiement P, Martel-Pelletier J; DISSCO Trial Investigator Group. An international, multicentre, double-blind, randomized study (DISSCO): effect of diacerein vs celecoxib on symptoms in knee osteoarthritis. Rheumatology (Oxford). 2020 Dec 1;59(12):3858-3868. doi: 10.1093/rheumatology/keaa072.

    PubMed 32521015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diacerein and Celecoxib in people with Osteoarthritis and Osteoarthritis, Knee, run by TRB Chemedica International SA at 22 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Canada, Spain, Czechia, Belgium, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change Form Baseline in WOMAC A Pain Subscale (time frame: baseline and 182 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688400, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.

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