Overview

Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Carbylan Therapeutics, Inc.
Treatments:
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Criteria
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