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

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Hydros

Hydros-TA

Triamcinolone Acetonide

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Hydros

Hydros-TA

Triamcinolone acetonide

Arm Description

Hydros Joint Therapy

Hydros-TA Joint Therapy

Triamcinolone acetonide

Outcomes

Primary Outcome Measures

Change from baseline in the WOMAC A subscale score for the treatment knee.

Secondary Outcome Measures

Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee

Full Information

NCT ID

NCT02022930

First Posted

December 23, 2013

Last Updated

August 24, 2016

Sponsor

Carbylan Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02022930

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Carbylan Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hydros

Arm Type

Experimental

Arm Description

Hydros Joint Therapy

Arm Title

Hydros-TA

Arm Type

Experimental

Arm Description

Hydros-TA Joint Therapy

Arm Title

Triamcinolone acetonide

Arm Type

Active Comparator

Arm Description

Triamcinolone acetonide

Intervention Type

Device

Intervention Name(s)

Hydros

Intervention Type

Device

Intervention Name(s)

Hydros-TA

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Primary Outcome Measure Information:

Title

Change from baseline in the WOMAC A subscale score for the treatment knee.

Time Frame

2 weeks and 26 weeks

Secondary Outcome Measure Information:

Title

Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

City

St.Leonards

State/Province

New South Wales

Country

Australia

City

London

State/Province

Ontario

Country

Canada

City

Oshawa

Country

Canada

City

Quebec City

Country

Canada

City

Willemstad

State/Province

Curacao

Country

Netherlands Antilles

12. IPD Sharing Statement

Learn more about this trial

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

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