Osteoarthritis of the KneePhase 3NCT02022930
Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
A Phase 3 study testing Hydros, Hydros-TA and Triamcinolone Acetonide in people with Osteoarthritis of the Knee, run by Carbylan Therapeutics, Inc. at 5 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Hydros, Hydros-TA and Triamcinolone Acetonide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2014to Jun 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
- Symptoms in the index knee for at least 12 months.
- Fully ambulatory Subject (ability to perform a 15 meters walk test).
- Male and female Subjects 40 through 85 years of age.
Who cannot join
- BMI >40 kg
- Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
- Intra articular steroid therapy in last 3 months
- Intra articular viscosupplementation in last 6 months
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Netherlands Antilles1 site
Study site
Willemstad, Curacao
About this study
Official title: A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee
The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Hydros, Hydros-TA, Triamcinolone Acetonide
- Keywords
- Osteoarthritis, Knee
- 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.
HydrosDevice
Hydros-TADevice
Triamcinolone AcetonideDrug
| Study group | Role | What they receive |
|---|---|---|
| Hydros | Experimental | Hydros Joint Therapy Receives: Device: Hydros |
| Hydros-TA | Experimental | Hydros-TA Joint Therapy Receives: Device: Hydros-TA |
| Triamcinolone acetonide | Active comparator | Triamcinolone acetonide Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the WOMAC A subscale score for the treatment knee.
Measured: 2 weeks and 26 weeks
Secondary outcomes (1)
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carbylan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022930
- Sponsor's protocol ID
- COR1.1
- Status last verified
- Aug 2016
- First submitted
- 23 Dec 2013
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated With Osteoarthritis in the Knee
- ClinicalTrials.gov ID
- NCT02022930
- Acronym / sponsor ID
- COR1.1
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Carbylan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Dec 2013 (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 the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydros | Experimental | Device: HydrosHydros Joint Therapy |
| Hydros-TA | Experimental | Device: Hydros-TAHydros-TA Joint Therapy |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone AcetonideTriamcinolone acetonide |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 using Kellgren-Lawrence Grading for OA.
- Symptoms in the index knee for at least 12 months.
- Fully ambulatory Subject (ability to perform a 15 meters walk test).
- Male and female Subjects 40 through 85 years of age.
Key exclusion criteria (4 listed)
- BMI >40 kg
- Secondary OA (acute knee injury, rheumatoid arthritis, gout, history of joint infection, osteonecrosis, chronic fibromyalgia) or other chronic autoimmune disease.
- Intra articular steroid therapy in last 3 months
- Intra articular viscosupplementation in last 6 months
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 |
|---|---|---|
| Hydros | Device | Hydros |
| Hydros-TA | Device | Hydros-TA |
| Triamcinolone Acetonide | Drug | Triamcinolone acetonide |
Primary outcome
Change from baseline in the WOMAC A subscale score for the treatment knee.
Time frame: 2 weeks and 26 weeks
1 secondary outcome
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
Time frame: 26 weeks
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 25 Aug 2016.
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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.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydros, Hydros-TA and Triamcinolone Acetonide in people with Osteoarthritis of the Knee, run by Carbylan Therapeutics, Inc. at 5 sites in 3 countries.
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 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Australia, Netherlands Antilles. 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 in the WOMAC A subscale score for the treatment knee. (time frame: 2 weeks and 26 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 25 Aug 2016.