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

Carbylan Therapeutics

Status: Terminated

Conditions: Osteoarthritis

Treatments: Other: ActaVisc and ActaVisc Mx Intra-articular Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00665574

AIM 1.0

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

ActaVisc

Treatment:

Other: ActaVisc and ActaVisc Mx Intra-articular Injection

2

Experimental group

Description:

ActaVisc Mx Intra-articular Injection

Treatment:

Other: ActaVisc and ActaVisc Mx Intra-articular Injection

3

Placebo Comparator group

Description:

Saline

Treatment:

Other: ActaVisc and ActaVisc Mx Intra-articular Injection

4

Active Comparator group

Description:

Corticosteroid

Treatment:

Other: ActaVisc and ActaVisc Mx Intra-articular Injection