Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02022930




Registration number
NCT02022930
Ethics application status
Date submitted
23/12/2013
Date registered
30/12/2013
Date last updated
25/08/2016

Titles & IDs
Public title
Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
Scientific 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
Secondary ID [1] 0 0
COR1.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Hydros
Treatment: Devices - Hydros-TA
Treatment: Drugs - Triamcinolone Acetonide

Experimental: Hydros - Hydros Joint Therapy

Experimental: Hydros-TA - Hydros-TA Joint Therapy

Active Comparator: Triamcinolone acetonide - Triamcinolone acetonide


Treatment: Devices: Hydros


Treatment: Devices: Hydros-TA


Treatment: Drugs: Triamcinolone Acetonide
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the WOMAC A subscale score for the treatment knee.
Timepoint [1] 0 0
2 weeks and 26 weeks
Secondary outcome [1] 0 0
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
Timepoint [1] 0 0
26 weeks

Eligibility
Key inclusion criteria
- 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.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- St.Leonards
Recruitment postcode(s) [1] 0 0
- St.Leonards
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Oshawa
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec City
Country [4] 0 0
Netherlands Antilles
State/province [4] 0 0
Curacao

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Carbylan Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02022930
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02022930