Osteoarthritis, KneePhase 2NCT01525758
Study of SI000413 in Knee Osteoarthritis Patients
A Phase 2 study testing SI000413 and microcrystalline cellulose in people with Osteoarthritis, Knee, run by Dong-A Pharmaceutical Co., Ltd. at 3 sites in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with knee osteoarthritis by orally administration and to determine optimal dose. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- SI000413 and microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 2
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 35-75 years old
- Subjects must have a clinical or radiographic diagnosis of primary OA of the knee (diagnosed according to the ACR)
- The presence of knee pain
- At least one of the following
- age older than 50 years
- morning stiffness lasting less than 30 minutes
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- crepitus with motion
- Subjects must have been symptomatic for at least 3 months prior to enrollment.
- Subjects must be required to have experienced a pain intensity of at least 40mm on a 100-mm visual analogue scale in the most severely affected joint during the 24 hours prior to randomization.
- Adequate liver and kidney function
- Adequate liver function : SGOT, SGPT must be within 1.5 x normal limit
- Adequate kidney function : Serum creatinine must be within 1.5 x normal limit
- Subjects must be able to read, understand and follow the study instructions
- Subjects must agree to informed consent spontaneously.
Who cannot join
- Subjects who are not using adequate birth control.
- Pregnant or breast-feeding.
- Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
- Secondary OA patients
- Similar OA patients(ex. rheumatic arthritis, bursitis etc)
- Treatment with intra-articular injections of systemic corticosteroids or hyaluronic acid in the prior 3 months.
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- Use of drugs or psychotropic medicine(methadone maintenance program, codeine, tramadol hydrochloride)
- Anemia or coagulant disorder
- Use of anticoagulants or lithium
- Use of misoprostol or H2-blocker(including anti ulcer medicine)
- Presence or history of gastrointestinal bleeding within the past 1 year.
- Subjects who have serious problem with cardiovascular, respiratory, endocrine, central nervous or History of neurotic mental.
- Active malignancy of any type(ex. lymphoma, multiple myeloma etc)
- Use of any medication that will affect pain perception during the study period; physical therapy, corticosteroids, NSAIDs, asprin, topical analgesics.
- Use of glucosamine, chondroitin during the study period.
- Change of concomitant dose/use within 4 weeks.
- Known allergy or hypersensitivity to medicine.
- Subjects received hormone replacement therapy.
- Use of any other investigational drug within 1 month prior to screening.
- Investigators determines that it is not appropriate.
Trial locations and contacts
3 sites in 1 country.
Yoon-Jae Cho, MD contact
South Korea3 sites, 3 recruiting
- Recruiting
Ajou University Medical Center
Gyeonggi-do, Woncheon-dong Yeongtong-gu, Suwon, 443-721
We-Yeon Won, MD
- Recruiting
KyungHee University medical center
Seoul, Hoegi-dong, Dongdaemun-gu, 130-872
Yoon-Jae Cho, MD
- Recruiting
Seoul National University Hospital
Seoul, Yongon-dong, Chongno-gu, 110-744
Myung-Chul Lee, MD
About this study
Official title: Eight-week, Multi-centre, Dose-response, Double Blind, Placebo-controlled, Randomized, Parallel-group, PhaseⅡ Trial to Evaluate Efficacy and Safety of SI000413 in Patients With Knee Osteoarthritis
The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with knee osteoarthritis by orally administration and to determine optimal dose.
Read the detailed description
This is a dose-response, double blind , placebo-controlled study. All patients are required to have 2 weeks washout period from prior medication. Subjects will discontinue current medications 2 weeks prior to randomization. Among those who meet the inclusion criteria, only subjects recording visual analogue scale(VAS) of higher than 40mm(VAS range from 0mm(no pain) to 100mm(unbearable pain)) are enrolled in this study.
Subjects meeting screening criteria will be randomized to receive 8 weeks dosing of an active dose of SI000413 or placebo.
- Conditions
- Osteoarthritis, Knee
- Being tested
- SI000413, microcrystalline cellulose
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI000413Drug
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
microcrystalline celluloseDrug
Also called SI000413 placebo
identical number of tablets to active drug groups
| Study group | Role | What they receive |
|---|---|---|
| SI000413 400mg | Experimental | tablet, SI000413 200mg bid Receives: Drug: SI000413 |
| SI000413 600mg | Experimental | tablet, SI000413 200mg tid Receives: Drug: SI000413 |
| SI000413 800mg | Experimental | SI000413 200mg, 2T bid Receives: Drug: SI000413 |
| placebo | Placebo comparator | placebo 2T tid for 8 weeks Receives: Drug: microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
K-WOMAC
The primary endpoint will be the change in the sum of the K-WOMAC OA index at Visit 6(8 weeks) vs. baseline(Visit 2, 0 week).
Measured: Visit 6(8 week), baseline
Secondary outcomes (4)
knee pain intensity assessment
The change from baseline to each day(4 week and 8 week). Subjects assess knee pain intensity by using 100mm VAS at each time.
Measured: baseline, Visit 4(4 week), Visit 6(8 week)
Global assessment(regarding to disease activity)
The change from Visit 4 to Visit 6 using 100mm VAS. Each patient and investigator assess by using 100mm VAS.
Measured: Visit 4(4 week), Visit 6(8 week)
K-WOMAC each domain assessment
The change from Visit 6(8 weeks) vs. baseline(Visit 2, 0 week) in the K-WOMAC each domain score.
- K-WOMAC 3 domains: pain domain, stiffness domain, physical function domain
Measured: baseline, Visit 6(8 week)
ESR & hs-CRP
The change from baseline to each day(Visit 4, Visit 6) using laboratory test.
Measured: baseline, Visit 4(4 week), Visit 6(8 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon-Jae Cho, MD, Study chair, Kyunghee University Medical CenterMyung-Chul Lee, MD, Principal investigator, Seoul National University HospitalWe-Yeon Won, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525758
- Sponsor's protocol ID
- SI000413_OA_Ⅱ
- Status last verified
- Aug 2013
- First submitted
- 31 Jan 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight-week, Multi-centre, Dose-response, Double Blind, Placebo-controlled, Randomized, Parallel-group, PhaseⅡ Trial to Evaluate Efficacy and Safety of SI000413 in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01525758
- Acronym / sponsor ID
- SI000413_OA_Ⅱ
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Feb 2012 (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.
The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with knee osteoarthritis by orally administration and to determine optimal dose.
Detailed description
This is a dose-response, double blind , placebo-controlled study. All patients are required to have 2 weeks washout period from prior medication. Subjects will discontinue current medications 2 weeks prior to randomization. Among those who meet the inclusion criteria, only subjects recording visual analogue scale(VAS) of higher than 40mm(VAS range from 0mm(no pain) to 100mm(unbearable pain)) are enrolled in this study.
Subjects meeting screening criteria will be randomized to receive 8 weeks dosing of an active dose of SI000413 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SI000413 400mg | Experimental | Drug: SI000413tablet, SI000413 200mg bid |
| SI000413 600mg | Experimental | Drug: SI000413tablet, SI000413 200mg tid |
| SI000413 800mg | Experimental | Drug: SI000413SI000413 200mg, 2T bid |
| placebo | Placebo comparator | Drug: microcrystalline celluloseplacebo 2T tid for 8 weeks |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females, 35-75 years old
- Subjects must have a clinical or radiographic diagnosis of primary OA of the knee (diagnosed according to the ACR)
- Subjects must have been symptomatic for at least 3 months prior to enrollment.
- Subjects must be required to have experienced a pain intensity of at least 40mm on a 100-mm visual analogue scale in the most severely affected joint during the 24 hours prior to randomization.
- Adequate liver and kidney function
Key exclusion criteria (20 listed)
- Subjects who are not using adequate birth control.
- Pregnant or breast-feeding.
- Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
- Secondary OA patients
- Similar OA patients(ex. rheumatic arthritis, bursitis etc)
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 |
|---|---|---|
| SI0004131 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks | Drug | SI000413 400mg, SI000413 600mg, SI000413 800mg |
| microcrystalline celluloseAlso: SI000413 placeboidentical number of tablets to active drug groups | Drug | placebo |
Primary outcome
K-WOMAC
Time frame: Visit 6(8 week), baseline
The primary endpoint will be the change in the sum of the K-WOMAC OA index at Visit 6(8 weeks) vs. baseline(Visit 2, 0 week).
4 secondary outcomes
knee pain intensity assessment
Time frame: baseline, Visit 4(4 week), Visit 6(8 week)
Global assessment(regarding to disease activity)
Time frame: Visit 4(4 week), Visit 6(8 week)
K-WOMAC each domain assessment
Time frame: baseline, Visit 6(8 week)
ESR & hs-CRP
Time frame: baseline, Visit 4(4 week), Visit 6(8 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
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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.
Yoon-Jae Cho, MD contact
Yoon-Jae Cho, MD study chair
Kyunghee University Medical Center
Myung-Chul Lee, MD principal investigator
Seoul National University Hospital
We-Yeon Won, MD principal investigator
Ajou University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SI000413 and microcrystalline cellulose in people with Osteoarthritis, Knee, run by Dong-A Pharmaceutical Co., Ltd. at 3 sites 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 14 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon-Jae Cho, MD (yjcho@khmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-WOMAC (time frame: Visit 6(8 week), baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2013.