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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
Sponsor:
Information provided by (Responsible Party):
Carbylan Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 23, 2013
First Posted Date  ICMJE December 30, 2013
Last Update Posted Date August 25, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
Change from baseline in the WOMAC A subscale score for the treatment knee. [ Time Frame: 2 weeks and 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee [ Time Frame: 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • Device: Hydros
  • Device: Hydros-TA
  • Drug: Triamcinolone Acetonide
Study Arms  ICMJE
  • Experimental: Hydros
    Hydros Joint Therapy
    Intervention: Device: Hydros
  • Experimental: Hydros-TA
    Hydros-TA Joint Therapy
    Intervention: Device: Hydros-TA
  • Active Comparator: Triamcinolone acetonide
    Triamcinolone acetonide
    Intervention: Drug: Triamcinolone Acetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 23, 2013)
510
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Netherlands Antilles
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02022930
Other Study ID Numbers  ICMJE COR1.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carbylan Therapeutics, Inc.
Study Sponsor  ICMJE Carbylan Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Carbylan Therapeutics, Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP