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

This study has been terminated.
(Business decision)
Sponsor:
Information provided by:
Carbylan BioSurgery, Inc.
ClinicalTrials.gov Identifier:
NCT00665574
First received: April 22, 2008
Last updated: July 13, 2009
Last verified: July 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 BioSurgery, Inc.:

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

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

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665574

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

No publications provided

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
Study First Received: April 22, 2008
Last Updated: July 13, 2009
Health Authority: Latvia: State Agency of Medicines

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

ClinicalTrials.gov processed this record on July 24, 2014