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

This study has been terminated.
(Business decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00665574
First Posted: April 24, 2008
Last Update Posted: July 14, 2009
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.
Information provided by:
Carbylan Therapeutics, Inc.
  Purpose
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 Intervention
Osteoarthritis Other: ActaVisc and ActaVisc Mx Intra-articular Injection

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Carbylan Therapeutics, Inc.:

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

Enrollment: 23
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: April 22, 2008
First Posted: April 24, 2008
Last Update Posted: July 14, 2009
Last Verified: July 2009

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