Hydros and Hydros-TA Joint Therapy for Pain Associated With Knee Osteoarthritis
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
1 other identifier
interventional
510
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2014
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 25, 2016
August 1, 2016
1.9 years
December 23, 2013
August 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the WOMAC A subscale score for the treatment knee.
2 weeks and 26 weeks
Secondary Outcomes (1)
Strict positive responders to treatment for symptomatic primary osteoarthritis of the knee
26 weeks
Study Arms (3)
Hydros
EXPERIMENTALHydros Joint Therapy
Hydros-TA
EXPERIMENTALHydros-TA Joint Therapy
Triamcinolone acetonide
ACTIVE COMPARATORTriamcinolone acetonide
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
St Leonards, New South Wales, Australia
Unknown Facility
London, Ontario, Canada
Unknown Facility
Oshawa, Canada
Unknown Facility
Québec, Canada
Unknown Facility
Willemstad, Curacao, Netherlands Antilles
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2013
First Posted
December 30, 2013
Study Start
January 1, 2014
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
August 25, 2016
Record last verified: 2016-08