Osteoarthritis of KneePhase 3NCT02893098
A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
A Phase 3 study testing Humia inj. and High hyal Plus inj. in people with Osteoarthritis of Knee, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Humia inj. and High hyal Plus inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Apr 2018
- Phase
- Phase 3
- 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
- Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain
- Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months
- Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm
- Able to walk without assistive devices
- Patients willing and able to provide signed informed consent after the nature of the study has been explained
Who cannot join
- Body Mass Index (BMI) > 32
- History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
- Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
- Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test
- Undergo Knee Replacement Surgery of the target knee
Trial locations and contacts
1 site in 1 country.
About this study
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
- Conditions
- Osteoarthritis of Knee
- Being tested
- Humia inj., High hyal Plus inj.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humia inj.Drug
Single injection of 3mL Humia inj.
Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
High hyal Plus inj.Drug
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Humia inj. | Experimental | Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj. Receives: Drug: Humia inj. |
| High Hyal Plus inj. | Active comparator | Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks Receives: Drug: High hyal Plus inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Weight-bearing pain (100mm-VAS)
Measured: Week 14
Secondary outcomes (8)
Change from baseline of Weight-bearing pain (100mm-VAS)
Measured: Weeks 3, 8, 14, and 26
Change from Visit 8 of Weight-bearing pain (100mm-VAS)
Measured: Week 38
Physical Examination : Swelling
Measured: Weeks 0, 3, 8, 14, 26, and 38
Physical Examination : Tenderness on pressure
Measured: Weeks 0,3,8,14,26,and 38
Physical Examination : Range of motion
Measured: Weeks 0, 3, 8, 14, 26, and 38
Consumption of rescue medication
Measured: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Proportion (%) of patients taking rescue medication
Measured: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Responder Rate
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893098
- Sponsor's protocol ID
- HU-025 P3
- Status last verified
- Apr 2018
- First submitted
- 17 Aug 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02893098
- Acronym / sponsor ID
- HU-025 P3
- Conditions
- Osteoarthritis of Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 8 Sep 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.
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humia inj. | Experimental | Drug: Humia inj.Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj. |
| High Hyal Plus inj. | Active comparator | Drug: High hyal Plus inj.Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain
- Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months
- Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm
- Able to walk without assistive devices
- Patients willing and able to provide signed informed consent after the nature of the study has been explained
Key exclusion criteria (5 listed)
- Body Mass Index (BMI) > 32
- History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
- Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
- Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test
- Undergo Knee Replacement Surgery of the target knee
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 |
|---|---|---|
| Humia inj.Single injection of 3mL Humia inj. Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks | Drug | Humia inj. |
| High hyal Plus inj.Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks | Drug | High Hyal Plus inj. |
Primary outcome
Change from baseline of Weight-bearing pain (100mm-VAS)
Time frame: Week 14
8 secondary outcomes
Change from baseline of Weight-bearing pain (100mm-VAS)
Time frame: Weeks 3, 8, 14, and 26
Change from Visit 8 of Weight-bearing pain (100mm-VAS)
Time frame: Week 38
Physical Examination : Swelling
Time frame: Weeks 0, 3, 8, 14, 26, and 38
Physical Examination : Tenderness on pressure
Time frame: Weeks 0,3,8,14,26,and 38
Physical Examination : Range of motion
Time frame: Weeks 0, 3, 8, 14, 26, and 38
Consumption of rescue medication
Time frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Proportion (%) of patients taking rescue medication
Time frame: Weeks 0, 1, 2, 3, 8, 14, 26, and 38
Responder Rate
Time frame: Week 14
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 12 Apr 2018.
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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.
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 Humia inj. and High hyal Plus inj. in people with Osteoarthritis of Knee, run by Huons Co., Ltd. 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 5 inclusion and 5 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 12 Apr 2018. 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. 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?
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 of Weight-bearing pain (100mm-VAS) (time frame: Week 14). 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 12 Apr 2018.