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

July 13, 2009 updated by: Carbylan Therapeutics, Inc.

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.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
      • Daugavpils, Latvia
        • Daugavpils Pilsetas Centrala Slimnica
      • Riga, Latvia
        • State Hospital of Traumatology and Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
Time Frame: 26 weeks post treatment
26 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carbylan Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 22, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

July 14, 2009

Last Update Submitted That Met QC Criteria

July 13, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIM 1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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