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

Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00665574
• Other study ID #: AIM 1.0
• Status: Terminated
• Phase: N/A
• First received: April 22, 2008
• Last updated: July 13, 2009
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Carbylan Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Latvia: State Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Latvia	Daugavpils Pilsetas Centrala Slimnica	Daugavpils
Latvia	State Hospital of Traumatology and Orthopaedics	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Carbylan Therapeutics, Inc.

Country where clinical trial is conducted

Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.		26 weeks post treatment	Yes