Back to resultsActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
Latvia
Study Type
Interventional
Intervention
ActaVisc and ActaVisc Mx Intra-articular Injection
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis (OA) grade 2 or 3.
- Symptoms in the treatment knee for at least 12 months.
- Fully ambulatory patient.
Exclusion Criteria:
- Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
Sites / Locations
- Daugavpils Pilsetas Centrala Slimnica
- State Hospital of Traumatology and Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
ActaVisc
ActaVisc Mx Intra-articular Injection
Saline
Corticosteroid
Outcomes
Primary Outcome Measures
Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
Secondary Outcome Measures
Full Information
NCT ID
NCT00665574
First Posted
April 22, 2008
Last Updated
July 13, 2009
Sponsor
Carbylan Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00665574
Brief Title
ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee
Official Title
A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of ActaVisc and ActaVisc Mx Intra-articular Injection for Management of Pain Associated With Osteoarthritis in the Knee.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Carbylan Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ActaVisc
Arm Title
2
Arm Type
Experimental
Arm Description
ActaVisc Mx Intra-articular Injection
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Saline
Arm Title
4
Arm Type
Active Comparator
Arm Description
Corticosteroid
Intervention Type
Other
Intervention Name(s)
ActaVisc and ActaVisc Mx Intra-articular Injection
Intervention Description
ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.
Primary Outcome Measure Information:
Title
Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
Time Frame
26 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis (OA) grade 2 or 3.
Symptoms in the treatment knee for at least 12 months.
Fully ambulatory patient.
Exclusion Criteria:
Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
Facility Information:
Facility Name
Daugavpils Pilsetas Centrala Slimnica
City
Daugavpils
Country
Latvia
Facility Name
State Hospital of Traumatology and Orthopaedics
City
Riga
Country
Latvia
12. IPD Sharing Statement
Learn more about this trial
ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee
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