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

August 24, 2016 updated by: Carbylan Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

510

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St.Leonards, New South Wales, Australia
  • Canada
      • Oshawa, Canada
      • Quebec City, Canada
    • Ontario
      • London, Ontario, Canada
  • Netherlands Antilles
    • Curacao
      • Willemstad, Curacao, Netherlands Antilles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the WOMAC A subscale score for the treatment knee.
Time Frame: 2 weeks and 26 weeks
2 weeks and 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carbylan Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR1.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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