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

A Phase 3 study testing Artrodar in people with Knee Osteoarthritis, run by TRB Chemedica at 1 site in Thailand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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. Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Artrodar
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 128 participants
Where: 1 siteThailand
Study dates: 22 Nov 2020to 31 Dec 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 40 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 21Show fewer

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Siriraj Hospital
Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

Read the 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).

Conditions: Knee Osteoarthritis
Being tested: Artrodar, Placebos
Medical subject headings: Osteoarthritis, Knee

What participants receive

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

ArtrodarDrug
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
PlacebosDrug
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 groups in NCT04318041
Study group	Role	What they receive
diacerein (Artrodar)	Experimental	Not described Receives: Drug: Artrodar
placebo	Placebo comparator	Not described Receives: Drug: Placebos

What is being measured

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

Cartilage volume measured by MRI of the affected knee.
Cartilage volume in cc
Measured: Change from Day 0 cartilage volume at Day 336, Day 672
Bone marrow lesions measured by MRI of the affected knee.
Bone marrow lesions in mm3
Measured: Change from Day 0 Bone marrow lesions at Day 336, Day 672
Synovitis measured by MRI of the affected knee.
Synovial tissue volume in mm3
Measured: Change from Day 0 Synovial tissue volume at Day 336, Day 672
Joint space width at narrowest point at medial compartment measured by X-ray (Full extension, weight-bearing position)
Joint space width in mm
Measured: Change from Day -7 to -30 Joint space width at Day 168, Day 336, Day 504, Day 672

Secondary outcomes (8)

Pain at rest
Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
Measured: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
Pain on walking at 15 meters
Visual analogue scale (VAS) 0-100 mm. 0 is no pain, 100 is extreme pain.
Measured: Day -7 to -30, Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
KOOs
Knee and Osteoarthritis Outcome Score from 1-5 Likert scale score with higher scores denoting worse pain and disability.
Measured: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
EQ5D5L
EQ5D5L is a standardized instrument for measuring generic health status
Measured: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
Time up-and-go test
Measured: 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
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.
Measured: Day 168, Day 336, Day 672
Rescued medicine consumption
Measured: Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
Oxford Knee Questionnaire
1-5 Likert scale score with higher scores denoting worse pain and disability.
Measured: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672

Timeline

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

22 Nov 202031 Dec 2026

First posted23 Mar 2020
Study start22 Nov 2020
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04318041
Sponsor's protocol ID: DAR-THA-19-01
Status last verified: Sep 2026
First submitted: 16 Mar 2020
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Holistic Healing for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Structural Modification Effect of Diacerein (Artrodar®) in Knee Osteoarthritic Patients
ClinicalTrials.gov ID: NCT04318041
Acronym / sponsor ID: DAR-THA-19-01
Conditions: Knee Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 128 participants (estimated)
Lead sponsor: TRB ChemedicaIndustry (pharma, biotech, devices)
Study start: 22 Nov 2020 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 23 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
diacerein (Artrodar)	Experimental	Drug: Artrodar
placebo	Placebo comparator	Drug: Placebos

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ArtrodarDiacerein (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	diacerein (Artrodar)
PlacebosPlacebo: D1-D28 (1 month): Placebo 1 x 1 with evening meal D29-end of study (23 months) Placebo 1 x 2 with meal	Drug	placebo

Primary outcome

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

8 secondary outcomes

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
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
KOOs
Time frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
EQ5D5L
Time frame: Day 0, Day 28, Day 84, Day 168, Day 252, Day 336, Day 420, Day 504, Day 588, Day 672
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
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nipaporn Jitsook study director

TRB Chemedica

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Artrodar in people with Knee Osteoarthritis, run by TRB Chemedica at 1 site in Thailand.

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 6 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Cartilage volume measured by MRI of the affected knee. (time frame: Change from Day 0 cartilage volume at Day 336, Day 672). The study lists 4 primary outcomes in all. 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 NCT04318041.

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 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.