OsteoarthritisPhase 4NCT00685542
Effect of Diacerein on Hand Osteoarthritis
A Phase 4 study testing diacerein in people with Osteoarthritis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people world-widely. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. It commonly affects knee, hip, hand and spine joints. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- diacerein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages over 40 years-old
- Conforming to the classification criteria of American College of Rheumatology*
- More than 1 tender joints
- Self reported hand pain which is more than 30 mm on the Australian/Canadian Osteoarthritis Hand Index visual analogue scales (VAS) after wash out period of 2 weeks
Who cannot join
- Pregnant or lactating women
- Previous history of hypersensitivity to Diacerein
- Patients who had taken oral corticosteroid or intraarticular steroid to hand joints within 3 months of enrollment
- Patients who were injected with hyaluronic acid to hand joints within 6 months of enrollment
- Patients who underwent surgery in any joints of the hands
- AST/ALT > 2x upper normal range
Show all 10Show fewer
- Serum Cr > 1.4 mg/dl
- Patients who have severe comorbidities such as severe congestive heart failure or pulmonary disease
- Patients who took oral anticoagulants.
- Patients who refuse to sign the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Diacerein in Human Hand Osteoarthritis
Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people world-widely. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. It commonly affects knee, hip, hand and spine joints. Diacerein is a drug developed specifically for the treatment of osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on animal models and reduced structural changes in several animal models. Therefore, we investigate the role of diacerein in patients with hand osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- diacerein, placebo
- Keywords
- diacerein, osteoarthritis, hand
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diacereinDrug
Also called Atrodar 50mg bid
Diacerein 50mg bid
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Diacerein 50mg bid Receives: Drug: diacerein |
| 2 | Placebo comparator | placebo 50mg bid Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point
Measured: 12 weeks
Secondary outcomes (2)
AUSCAN stiffness score at 4 week point
Measured: 12wks
AUSCAN pain score at 12 week point
Measured: 12wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Myungmoon Pharm. Co.
- Investigators
- Eun Bong Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685542
- Sponsor's protocol ID
- H-081-043-232
- Status last verified
- Dec 2010
- First submitted
- 24 May 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shin K, Kim JW, Moon KW, Yang JA, Lee EY, Song YW, Lee EB. The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study. Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6.
PubMed 23474153
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Diacerein in Human Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT00685542
- Acronym / sponsor ID
- H-081-043-232
- Conditions
- Osteoarthritis
- Keywords
- diacerein, osteoarthritis, hand
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Myungmoon Pharm. Co.
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 May 2008 (estimated)
- 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.
Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people world-widely. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. It commonly affects knee, hip, hand and spine joints. Diacerein is a drug developed specifically for the treatment of osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on animal models and reduced structural changes in several animal models. Therefore, we investigate the role of diacerein in patients with hand osteoarthritis.
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 |
|---|---|---|
| 1 | Experimental | Drug: diacereinDiacerein 50mg bid |
| 2 | Placebo comparator | Drug: placeboplacebo 50mg bid |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages over 40 years-old
- Conforming to the classification criteria of American College of Rheumatology*
- More than 1 tender joints
- Self reported hand pain which is more than 30 mm on the Australian/Canadian Osteoarthritis Hand Index visual analogue scales (VAS) after wash out period of 2 weeks
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Previous history of hypersensitivity to Diacerein
- Patients who had taken oral corticosteroid or intraarticular steroid to hand joints within 3 months of enrollment
- Patients who were injected with hyaluronic acid to hand joints within 6 months of enrollment
- Patients who underwent surgery in any joints of the hands
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 |
|---|---|---|
| diacereinAlso: Atrodar 50mg bidDiacerein 50mg bid | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point
Time frame: 12 weeks
2 secondary outcomes
AUSCAN stiffness score at 4 week point
Time frame: 12wks
AUSCAN pain score at 12 week point
Time frame: 12wk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
- Derived from this study: PubMed 23474153Shin K, Kim JW, Moon KW, Yang JA, Lee EY, Song YW, Lee EB. The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study. Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6.
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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.
Eun Bong Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing diacerein in people with Osteoarthritis, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 10 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 3 Dec 2010. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point (time frame: 12 weeks). 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 NCT00685542, which also lists 1 linked publication.
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 3 Dec 2010.