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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022930
• Other study ID #: COR1.1
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2013
• Last updated: August 24, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Carbylan Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Hydros

• Hydros-TA

Drug:
• Triamcinolone Acetonide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carbylan Therapeutics, Inc.

Countries where clinical trial is conducted

Australia,  Canada,  Netherlands Antilles, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the WOMAC A subscale score for the treatment knee.		2 weeks and 26 weeks	No
Secondary	Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee		26 weeks	No