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Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients

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ClinicalTrials.gov Identifier: NCT04318041
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica

Tracking Information
First Submitted Date  ICMJE March 16, 2020
First Posted Date  ICMJE March 23, 2020
Last Update Posted Date July 23, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
  • Cartilage volume measured by MRI of the affected knee. [ Time Frame: Change from Day 0 cartilage volume at Day 336, Day 672 ]
    Cartilage volume in cc
  • Bone marrow lesions measured by MRI of the affected knee. [ Time Frame: Change from Day 0 Bone marrow lesions at Day 336, Day 672 ]
    Bone marrow lesions in mm3
  • Synovitis measured by MRI of the affected knee. [ Time Frame: Change from Day 0 Synovial tissue volume at Day 336, Day 672 ]
    Synovial tissue volume in mm3
  • Joint space width at narrowest point at medial compartment measured by X-ray (Full extension, weight-bearing position) [ Time Frame: Change from Day -7 to -30 Joint space width at Day 168, Day 336, Day 504, Day 672 ]
    Joint space width in mm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2020)
  • Pain at rest [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
  • Pain on walking at 15 meters [ Time Frame: Day -7 to -30, Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
  • KOOs [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    Knee and Osteoarthritis Outcome Score from 1-5 Likert scale score with higher scores denoting worse pain and disability.
  • EQ5D5L [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    EQ5D5L is a standardized instrument for measuring generic health status
  • Time up-and-go test [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
  • Physician and Patient's global assessment [ Time Frame: Day 168, Day 336, Day 672 ]
    Visual analogue scale (VAS) 0-100 mm to assess efficacy and tolerability by physician and patient. 0 is not effective/ no tolerate, 100 is very effective/ very good.
  • Rescued medicine consumption [ Time Frame: Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
  • Oxford Knee Questionnaire [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    1-5 Likert scale score with higher scores denoting worse pain and disability.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2020)
  • Pain at rest [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
  • Pain on walking at 15 meters [ Time Frame: Day -7 to -30, Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
  • WOMAC [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    The Western Ontario and McMaster Universities Osteoarthritis Index range from 0-10 score with higher scores denoting worse pain and disability.
  • EQ5D5L [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
    EQ5D5L is a standardized instrument for measuring generic health status
  • Time up-and-go test [ Time Frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
  • Physician and Patient's global assessment [ Time Frame: Day 168, Day 336, Day 672 ]
    Visual analogue scale (VAS) 0-100 mm to assess efficacy and tolerability by physician and patient. 0 is not effective/ no tolerate, 100 is very effective/ very good.
  • Rescued medicine consumption [ Time Frame: Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Official Title  ICMJE Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Brief Summary This study evaluates the structure-modifying effect of Diacerein (Artrodar ®) in knee osteoarthritic (OA) patients by measuring total cartilage volume from magnetic resonance imaging (MRI) of the knee. Half of participants will receive Diacerein (Artrodar ®), while the other half will receive a placebo.
Detailed Description Diacerein (Artrodar ®) participants take 1x1 with evening meal for 1 month (D1-D28) then 1x2 with morning and evening meal for 23 months (D29-end of study). Placebo participants take 1x1 with evening meal for 1 month (D1-D28) then 1x2 with morning and evening meal for 23 months (D29-end of study).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Investigator, hospital pharmacists and monitors are blind to the treatment. The analysis of the results will be performed blind.
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Drug: Artrodar

    Diacerein (Artrodar):

    D1-D28 (1 month): Artrodar (50 mg) 1 x 1 with evening meal D29-end of study (23 months): Artrodar (50 mg) 1 x 2 with meal

  • Drug: Placebos

    Placebo:

    D1-D28 (1 month): Placebo 1 x 1 with evening meal D29-end of study (23 months) Placebo 1 x 2 with meal

Study Arms  ICMJE
  • Experimental: diacerein (Artrodar)
    Intervention: Drug: Artrodar
  • Placebo Comparator: placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 21, 2020)
128
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2020)
100
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients aged between 40 and 65 years who diagnosed with primary OA knee (medial tibiofemoral compartment) according to ACR criteria
  2. Grade II-III OA severity that classified by the Kellgren-Lawrence classification
  3. Varus malalignment ≤ 15°
  4. Body mass index (BMI) ≤ 30 kg/m2
  5. Pain on walking at 15 metres ≥ 30 mm using 100 mm visual analogue pain score (VAPS)
  6. Evidence of adequate contraceptive methods in women of childbearing age

Exclusion Criteria:

  1. Accompanying osteoarthritis of the hip of sufficient severity to interfere with the functional assessment of the knee
  2. Intra-articular treatment with any product (corticosteroids in the last 3 months, glycosaminoglycans, hyaluronic acid in the last 6 months, etc.), joint lavage or arthroscopic procedures within 6 months before the start of the study
  3. Oral corticosteroids, oral symptomatic slow acting drug for OA (SYSADOA) treatment (chondroitin sulfate, glucosamine sulfate, piascledin, diacerein) within last 3 months
  4. Current treatment with anti-depressants, tranquilisers, antacids or antibiotics
  5. Poor general health or other conditions which would make regular hospital attendance difficult
  6. Primary inflammatory painful conditions of the knee (e.g. rheumatoid arthritis, psoriatic arthropathy, pseudo-gout)
  7. Painful knee conditions other than osteoarthritis (e.g. Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis)
  8. Evolving arthritis requiring surgery within the coming year;
  9. Persistent diarrhoea (> 3 stools /24 h) or laxative use (any laxative use is to be stopped before inclusion in the trial)
  10. Severe gastrointestinal disorders, indications or history of severe gastrointestinal disorders (e.g. gastric or duodenal ulcers, ulcerative colitis, Crohn's syndrome, diverticulitis, recurrent pancreatitis)
  11. Renal insufficiency (estimate glomerular filtration rate ≤ 60 ml/min/1.73 m2)
  12. Hepatic disease (transaminases > 2.5 x upper limit of normal values (ULN) or total bilirubin > 2 x ULN) or history of alcoholism and liver disease
  13. Severe parenchymal organ disease
  14. History of heart attack or stroke, or have had serious diseases of the heart such as congestive heart failure, or taking clopidogrel.
  15. Patient with diabetes mellitus (DM) who has heamoglobin A1c level > 8%
  16. Patient with hypertension who has systolic blood pressure > 150 mmHg or diastolic Blood pressure > 95 mmHg
  17. Pregnancy or lactation
  18. Participation in a drug clinical trial within the 3 months before the start of the study;
  19. Ascertained hypersensitivity to the active ingredient diacerein, to similar compounds, to the excipients or to paracetamol, naproxen, and omeprazole
  20. Contraindications for magnetic resonance imaging (MRI) assessment such as heart pacemaker, aneurysm clip or claustrophobia
  21. Knee size measured at lower thigh > 50 cm
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Juree Patarasuwankul +66 (0)2 264 20 10 juree.p@trbchemedica.co.th
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04318041
Other Study ID Numbers  ICMJE DAR-THA-19-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TRB Chemedica
Study Sponsor  ICMJE TRB Chemedica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nipaporn Jitsook TRB Chemedica
PRS Account TRB Chemedica
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP