Back to resultsEvaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Artrodar
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 40 and 65 years who diagnosed with primary OA knee (medial tibiofemoral compartment) according to ACR criteria
- Grade II-III OA severity that classified by the Kellgren-Lawrence classification
- Varus malalignment ≤ 15°
- Body mass index (BMI) ≤ 30 kg/m2
- Pain on walking at 15 metres ≥ 30 mm using 100 mm visual analogue pain score (VAPS)
- Evidence of adequate contraceptive methods in women of childbearing age
Exclusion Criteria:
- Accompanying osteoarthritis of the hip of sufficient severity to interfere with the functional assessment of the knee
- 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
- Oral corticosteroids, oral symptomatic slow acting drug for OA (SYSADOA) treatment (chondroitin sulfate, glucosamine sulfate, piascledin, diacerein) within last 3 months
- Current treatment with anti-depressants, tranquilisers, antacids or antibiotics
- Poor general health or other conditions which would make regular hospital attendance difficult
- Primary inflammatory painful conditions of the knee (e.g. rheumatoid arthritis, psoriatic arthropathy, pseudo-gout)
- Painful knee conditions other than osteoarthritis (e.g. Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis)
- Evolving arthritis requiring surgery within the coming year;
- Persistent diarrhoea (> 3 stools /24 h) or laxative use (any laxative use is to be stopped before inclusion in the trial)
- Severe gastrointestinal disorders, indications or history of severe gastrointestinal disorders (e.g. gastric or duodenal ulcers, ulcerative colitis, Crohn's syndrome, diverticulitis, recurrent pancreatitis)
- Renal insufficiency (estimate glomerular filtration rate ≤ 60 ml/min/1.73 m2)
- 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
- Severe parenchymal organ disease
- History of heart attack or stroke, or have had serious diseases of the heart such as congestive heart failure, or taking clopidogrel.
- Patient with diabetes mellitus (DM) who has heamoglobin A1c level > 8%
- Patient with hypertension who has systolic blood pressure > 150 mmHg or diastolic Blood pressure > 95 mmHg
- Pregnancy or lactation
- Participation in a drug clinical trial within the 3 months before the start of the study;
- Ascertained hypersensitivity to the active ingredient diacerein, to similar compounds, to the excipients or to paracetamol, naproxen, and omeprazole
- Contraindications for magnetic resonance imaging (MRI) assessment such as heart pacemaker, aneurysm clip or claustrophobia
- Knee size measured at lower thigh > 50 cm
Sites / Locations
- Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
diacerein (Artrodar)
placebo
Arm Description
Outcomes
Primary Outcome Measures
Cartilage volume measured by MRI of the affected knee.
Cartilage volume in cc
Bone marrow lesions measured by MRI of the affected knee.
Bone marrow lesions in mm3
Synovitis measured by MRI of the affected knee.
Synovial tissue volume in mm3
Joint space width at narrowest point at medial compartment measured by X-ray (Full extension, weight-bearing position)
Joint space width in mm
Secondary Outcome Measures
Pain at rest
Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
Pain on walking at 15 meters
Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
KOOs
Knee and Osteoarthritis Outcome Score from 1-5 Likert scale score with higher scores denoting worse pain and disability.
EQ5D5L
EQ5D5L is a standardized instrument for measuring generic health status
Time up-and-go test
Physician and Patient's global assessment
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
Oxford Knee Questionnaire
1-5 Likert scale score with higher scores denoting worse pain and disability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04318041
Brief Title
Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Official Title
Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRB Chemedica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigator, hospital pharmacists and monitors are blind to the treatment. The analysis of the results will be performed blind.
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diacerein (Artrodar)
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Artrodar
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo:
D1-D28 (1 month): Placebo 1 x 1 with evening meal D29-end of study (23 months) Placebo 1 x 2 with meal
Primary Outcome Measure Information:
Title
Cartilage volume measured by MRI of the affected knee.
Description
Cartilage volume in cc
Time Frame
Change from Day 0 cartilage volume at Day 336, Day 672
Title
Bone marrow lesions measured by MRI of the affected knee.
Description
Bone marrow lesions in mm3
Time Frame
Change from Day 0 Bone marrow lesions at Day 336, Day 672
Title
Synovitis measured by MRI of the affected knee.
Description
Synovial tissue volume in mm3
Time Frame
Change from Day 0 Synovial tissue volume at Day 336, Day 672
Title
Joint space width at narrowest point at medial compartment measured by X-ray (Full extension, weight-bearing position)
Description
Joint space width in mm
Time Frame
Change from Day -7 to -30 Joint space width at Day 168, Day 336, Day 504, Day 672
Secondary Outcome Measure Information:
Title
Pain at rest
Description
Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
Time Frame
Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
Title
Pain on walking at 15 meters
Description
Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
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
Title
KOOs
Description
Knee and Osteoarthritis Outcome Score from 1-5 Likert scale score with higher scores denoting worse pain and disability.
Time Frame
Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
Title
EQ5D5L
Description
EQ5D5L is a standardized instrument for measuring generic health status
Time Frame
Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
Title
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
Title
Physician and Patient's global assessment
Description
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.
Time Frame
Day 168, Day 336, Day 672
Title
Rescued medicine consumption
Time Frame
Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
Title
Oxford Knee Questionnaire
Description
1-5 Likert scale score with higher scores denoting worse pain and disability.
Time Frame
Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged between 40 and 65 years who diagnosed with primary OA knee (medial tibiofemoral compartment) according to ACR criteria
Grade II-III OA severity that classified by the Kellgren-Lawrence classification
Varus malalignment ≤ 15°
Body mass index (BMI) ≤ 30 kg/m2
Pain on walking at 15 metres ≥ 30 mm using 100 mm visual analogue pain score (VAPS)
Evidence of adequate contraceptive methods in women of childbearing age
Exclusion Criteria:
Accompanying osteoarthritis of the hip of sufficient severity to interfere with the functional assessment of the knee
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
Oral corticosteroids, oral symptomatic slow acting drug for OA (SYSADOA) treatment (chondroitin sulfate, glucosamine sulfate, piascledin, diacerein) within last 3 months
Current treatment with anti-depressants, tranquilisers, antacids or antibiotics
Poor general health or other conditions which would make regular hospital attendance difficult
Primary inflammatory painful conditions of the knee (e.g. rheumatoid arthritis, psoriatic arthropathy, pseudo-gout)
Painful knee conditions other than osteoarthritis (e.g. Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis)
Evolving arthritis requiring surgery within the coming year;
Persistent diarrhoea (> 3 stools /24 h) or laxative use (any laxative use is to be stopped before inclusion in the trial)
Severe gastrointestinal disorders, indications or history of severe gastrointestinal disorders (e.g. gastric or duodenal ulcers, ulcerative colitis, Crohn's syndrome, diverticulitis, recurrent pancreatitis)
Renal insufficiency (estimate glomerular filtration rate ≤ 60 ml/min/1.73 m2)
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
Severe parenchymal organ disease
History of heart attack or stroke, or have had serious diseases of the heart such as congestive heart failure, or taking clopidogrel.
Patient with diabetes mellitus (DM) who has heamoglobin A1c level > 8%
Patient with hypertension who has systolic blood pressure > 150 mmHg or diastolic Blood pressure > 95 mmHg
Pregnancy or lactation
Participation in a drug clinical trial within the 3 months before the start of the study;
Ascertained hypersensitivity to the active ingredient diacerein, to similar compounds, to the excipients or to paracetamol, naproxen, and omeprazole
Contraindications for magnetic resonance imaging (MRI) assessment such as heart pacemaker, aneurysm clip or claustrophobia
Knee size measured at lower thigh > 50 cm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juree Patarasuwankul
Phone
+66 (0)2 264 20 10
Ext
1308
Email
juree.p@trbchemedica.co.th
First Name & Middle Initial & Last Name or Official Title & Degree
Waraporn Sanguanworapong
Phone
+66 (0)2 2642010
Ext
1301
Email
waraporn.s@trbchemedica.co.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nipaporn Jitsook
Organizational Affiliation
TRB Chemedica
Official's Role
Study Director
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keerati Chareancholvanich, MD.
Phone
66818188568
First Name & Middle Initial & Last Name & Degree
Keerati Chareancholvanich, MD.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
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