Osteoarthritis, KneePhase 2NCT03209362
SI-613 Study for Knee Osteoarthritis
A Phase 2 study testing SI-613 in people with Osteoarthritis, Knee, run by Seikagaku Corporation at 10 sites in United States.
Trial summary
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- SI-613
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Oct 2017to 13 Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provides their written informed consent.
- Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
- Is willing to switch to using acetaminophen as a rescue medication
Who cannot join
- Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
- Secondary OA
- Is a female subject who is pregnant or lactating.
- Is currently hospitalized or has a planned hospitalization during the life of the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Central Kentucky Research Associates
Lexington, Kentucky, 40509
MM Medical Center, Inc.
Miami, Florida, 33185
Quality Research and Medical Center, LLC
Miami, Florida, 33186
Heartland Research Associates, LLC
Newton, Kansas, 67114
Rochester Clinical Research
Rochester, New York, 14609
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- SI-613, Placebo
- Keywords
- Knee, Osteoarthritis, Intra-articular injection
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI-613Combination product
SI-613 will be repeated intra-articularly administered.
PlaceboCombination product
Placebo will be repeated intra-articularly administered.
| Study group | Role | What they receive |
|---|---|---|
| SI-613 | Experimental | Not described Receives: Combination Product: SI-613 |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.
Measured: Baseline over 12 weeks
Secondary outcomes (4)
Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Measured: Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26
Observed VAS of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Measured: Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26
Observed VAS of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Changes in score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Measured: Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Total Score at Weeks 12 and 26
WOMAC total score was the mean of WOMAC pain, physical function and stiffness subscores and ranges from 0 to 100 mm, where higher scores indicated worse response. Changes in WOMAC total score from baseline at Weeks 12 and 26 were analyzed using a longitudinal model.
Measured: Baseline, Weeks 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start19 Oct 2017
- Primary completion17 Aug 2018
- Study completion13 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seikagaku Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209362
- Sponsor's protocol ID
- 613 /1121
- Status last verified
- Nov 2021
- First submitted
- 4 Jul 2017
- Last updated
- 4 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03209362
- Acronym / sponsor ID
- 613 /1121
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee, Osteoarthritis, Intra-articular injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seikagaku CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Chiltern International Inc.
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.
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 |
|---|---|---|
| SI-613 | Experimental | Combination Product: SI-613 |
| Placebo | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provides their written informed consent.
- Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
- Is willing to switch to using acetaminophen as a rescue medication
Key exclusion criteria (4 listed)
- Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
- Secondary OA
- Is a female subject who is pregnant or lactating.
- Is currently hospitalized or has a planned hospitalization during the life of the study.
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 |
|---|---|---|
| SI-613SI-613 will be repeated intra-articularly administered. | Combination product | SI-613 |
| PlaceboPlacebo will be repeated intra-articularly administered. | Combination product | Placebo |
Primary outcome
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
Time frame: Baseline over 12 weeks
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.
4 secondary outcomes
Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26
Time frame: Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26
Time frame: Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26
Time frame: Baseline, Weeks 12 and 26
Change From Baseline in WOMAC Total Score at Weeks 12 and 26
Time frame: Baseline, Weeks 12 and 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 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 SI-613 in people with Osteoarthritis, Knee, run by Seikagaku Corporation at 10 sites in United States.
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 4 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks (time frame: Baseline over 12 weeks). 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 4 Nov 2021.