Hydros and Hydros-TA Joint Therapy for Pain Associated Wi... | NCT02022930

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

NCT02022930

Sponsor

Carbylan Therapeutics, Inc.

Status

Completed

Last Update Posted

Aug 25, 2016Estimated

Enrollment

510Estimated

Phase

Phase 3

Conditions

Osteoarthritis of the Knee

Interventions

Hydros
Hydros-TA
Triamcinolone Acetonide

Countries

Australia
Canada
Netherlands Antilles

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Dec 23, 2013

First Submission Date that Met QC Criteria

Dec 23, 2013

First Posted Date

Dec 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2016

Last Update Posted Date

Aug 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

510Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydros	Experimental	Hydros Joint Therapy	Device: Hydros
Hydros-TA	Experimental	Hydros-TA Joint Therapy	Device: Hydros-TA
Triamcinolone acetonide	Active Comparator	Triamcinolone acetonide	Drug: Triamcinolone Acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydros	Device		Hydros
Hydros-TA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		St Leonards	New South Wales		Australia

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D014221	Triamcinolone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided