Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
Phase 3
Completed
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Registration Number
- NCT02022930
- Lead Sponsor
- Carbylan Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 510
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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydros Hydros Hydros Joint Therapy Hydros-TA Hydros-TA Hydros-TA Joint Therapy Triamcinolone acetonide Triamcinolone Acetonide Triamcinolone acetonide
- Primary Outcome Measures
Name Time Method Change from baseline in the WOMAC A subscale score for the treatment knee. 2 weeks and 26 weeks
- Secondary Outcome Measures
Name Time Method Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee 26 weeks