Knee OsteoarthritisPhase 2NCT02759198
A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
A Phase 2 study testing YH23537 and Celecoxib in people with Knee Osteoarthritis, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- YH23537 and Celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2016to 26 Sep 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Men and women ≥ 40 years of age
- Patients with knee osteoarthritis at one or both knee by ACR
Who cannot join
- Patients with known or suspected secondary knee osteoarthritis
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo- and Active-Controlled, Multicenter, Phase 2 Trial to Evaluate the Efficacy and Safety of YH23537 in Patients With Osteoarthritis of the Knee
The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- YH23537, Celecoxib, YH23537 placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH23537Drug
Also called YH23537 750mg/1500mg/3000mg
Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg
CelecoxibDrug
Also called Celecoxib 200mg
Drug: Celecoxib 200mg
YH23537 placeboDrug
Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo
| Study group | Role | What they receive |
|---|---|---|
| YH23537 | Experimental | YH23537 750/1500/3000mg Receives: Drug: YH23537 |
| Celebrex | Active comparator | Celecoxib 200mg Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | YH23537 Placebo Receives: Drug: YH23537 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in VAS score to assess pain at Week 12
Measured: baseline and week 12
Secondary outcomes (6)
Change From Baseline in VAS score to assess pain at Week 4, 8
Measured: baseline, week 4 and week 8
Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12
Measured: baseline, week 4, week 8 and week 12
Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12
Measured: baseline, week 4, week 8 and week 12
Percentage From Baseline in WOMAC responder at Week 4, 8, 12
Measured: baseline, week 4, week 8 and week 12
Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12
Measured: week 12
Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start2 May 2016
- Primary completion24 May 2017
- Study completion26 Sep 2017
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.
- More trials run by Yuhan CorporationThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon Je Cho, M.D, Ph.D, Study chair, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759198
- Sponsor's protocol ID
- YH23537-202
- Status last verified
- Jan 2019
- First submitted
- 21 Apr 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo- and Active-Controlled, Multicenter, Phase 2 Trial to Evaluate the Efficacy and Safety of YH23537 in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02759198
- Acronym / sponsor ID
- YH23537-202
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 May 2016 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 26 Sep 2017 (actual)
- First posted
- 3 May 2016 (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 YH23537 versus celebrex in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YH23537 | Experimental | Drug: YH23537YH23537 750/1500/3000mg |
| Celebrex | Active comparator | Drug: CelecoxibCelecoxib 200mg |
| Placebo | Placebo comparator | Drug: YH23537 placeboYH23537 Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Men and women ≥ 40 years of age
- Patients with knee osteoarthritis at one or both knee by ACR
Key exclusion criteria (2 listed)
- Patients with known or suspected secondary knee osteoarthritis
- Other exclusions applied
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 |
|---|---|---|
| YH23537Also: YH23537 750mg/1500mg/3000mgDrug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg | Drug | YH23537 |
| CelecoxibAlso: Celecoxib 200mgDrug: Celecoxib 200mg | Drug | Celebrex |
| YH23537 placeboDrug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo | Drug | Placebo |
Primary outcome
Change From Baseline in VAS score to assess pain at Week 12
Time frame: baseline and week 12
6 secondary outcomes
Change From Baseline in VAS score to assess pain at Week 4, 8
Time frame: baseline, week 4 and week 8
Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12
Time frame: baseline, week 4, week 8 and week 12
Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12
Time frame: baseline, week 4, week 8 and week 12
Percentage From Baseline in WOMAC responder at Week 4, 8, 12
Time frame: baseline, week 4, week 8 and week 12
Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12
Time frame: week 12
Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12
Time frame: week 12
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 16 Jan 2019.
- 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.
Knee Osteoarthritis
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 Je Cho, M.D, Ph.D study chair
Kyunghee University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YH23537 and Celecoxib in people with Knee Osteoarthritis, run by Yuhan Corporation 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 3 inclusion and 2 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 16 Jan 2019. 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 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?
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?
Change From Baseline in VAS score to assess pain at Week 12 (time frame: baseline and week 12). 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 16 Jan 2019.