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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT02688400
• Date of registration: 10/02/2016
• Prospective Registration: Yes
• Primary sponsor: TRB Chemedica International SA
• Public title: Effect of Diacerein vs Celecoxib on Symptoms and Structural Changes in Symptomatic Knee Osteoarthritis DISSCO
• Scientific 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
• Date of first enrolment: May 2016
• Target sample size: 380
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02688400
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Czechia, Spain

Contacts

• Name: Jean-Pierre Pelletier, MD, FRCPC
• Affiliation: ArthroLab Inc.

• Name: Jean-Pierre Raynauld, MD, FRCPC
• Affiliation: Osteoarthritis Research Unit, University of Montreal Hospital Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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;

- 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.

Exclusion Criteria:

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;

- 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);




Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis, Knee

Osteoarthritis

Intervention(s)

Drug: Placebo

Drug: Celecoxib

Drug: Diacerein

Primary Outcome(s)

Change Form Baseline in WOMAC A Pain Subscale [Time Frame: baseline and 182 days]

Secondary Outcome(s)

Assessment of Joint Swelling, Effusion or Both [Time Frame: Day 182 or early termination]

Consumption of Acetaminophen [Time Frame: Day 182 or early termination]

Global Assessment of Response to Therapy [Time Frame: Day 182 or early termination]

OARSI Responders [Time Frame: Day 182 or early termination]

Quality of Life SF-36 [Time Frame: Day 182 or early termination]

Change From Baseline in Patient's Global Assessment of Disease Activity [Time Frame: Day 182 or early termination]

Absolute Changes From Baseline in Pain Visual Analogue Scale [Time Frame: Day 182 or early termination]

Change From Baseline in WOMAC OA Scores [Time Frame: Day 182 or early termination]

Secondary ID(s)

2015-002933-23

DAR-INT-14-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ArthroLab Inc.

Results

• Results available: Yes
• Date Posted: 01/12/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02688400