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ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee

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ClinicalTrials.gov Identifier: NCT00665574
Recruitment Status : Terminated (Business decision)
First Posted : April 24, 2008
Last Update Posted : July 14, 2009
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Osteoarthritis Other: ActaVisc and ActaVisc Mx Intra-articular Injection

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2008
Primary Completion Date : January 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
ActaVisc
Other: ActaVisc and ActaVisc Mx Intra-articular Injection
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.
Experimental: 2
ActaVisc Mx Intra-articular Injection
Other: ActaVisc and ActaVisc Mx Intra-articular Injection
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.
Placebo Comparator: 3
Saline
Other: ActaVisc and ActaVisc Mx Intra-articular Injection
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.
Active Comparator: 4
Corticosteroid
Other: ActaVisc and ActaVisc Mx Intra-articular Injection
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.


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline in the WOMAC Pain subscale average score for the treatment knee. [ Time Frame: 26 weeks post treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665574


Locations
Latvia
Daugavpils Pilsetas Centrala Slimnica
Daugavpils, Latvia
State Hospital of Traumatology and Orthopaedics
Riga, Latvia
Sponsors and Collaborators
Carbylan Therapeutics, Inc.
More Information

Responsible Party: Marcee Maroney, V.P. Marketing and Clinical Affairs, Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier: NCT00665574     History of Changes
Other Study ID Numbers: AIM 1.0
First Posted: April 24, 2008    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases