We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02022930
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : August 25, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Device: Hydros Device: Hydros-TA Drug: Triamcinolone Acetonide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Hydros
Hydros Joint Therapy
Device: Hydros
Experimental: Hydros-TA
Hydros-TA Joint Therapy
Device: Hydros-TA
Active Comparator: Triamcinolone acetonide
Triamcinolone acetonide
Drug: Triamcinolone Acetonide

Primary Outcome Measures :
  1. Change from baseline in the WOMAC A subscale score for the treatment knee. [ Time Frame: 2 weeks and 26 weeks ]

Secondary Outcome Measures :
  1. Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee [ Time Frame: 26 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022930

Layout table for location information
Australia, New South Wales
St.Leonards, New South Wales, Australia
Canada, Ontario
London, Ontario, Canada
Oshawa, Canada
Quebec City, Canada
Netherlands Antilles
Willemstad, Curacao, Netherlands Antilles
Sponsors and Collaborators
Carbylan Therapeutics, Inc.
Layout table for additonal information
Responsible Party: Carbylan Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02022930    
Other Study ID Numbers: COR1.1
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Keywords provided by Carbylan Therapeutics, Inc.:
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action