AP-004-A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 35 - 85 |
| Updated: | 7/29/2016 |
| Start Date: | December 2013 |
| End Date: | August 2014 |
A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of AmpionTM (<5 Kilodalton Ultrafiltrate of 5% Human Serum Albumin) in Adults With Pain Due to Osteoarthritis (OA) of the Knee
This is a randomized, placebo-controlled, double-blind study in which 500 patients with
osteoarthritis (OA) knee pain will be randomized to Ampion or placebo and followed for 20
weeks. The clinical effects of treatment on OA pain will be evaluated during clinic visits
at 6, 12, and 20 weeks using WOMAC® osteoarthritis Index and the Patient's Global Assessment
of disease severity (PGA). Safety will be assessed by recording adverse events, concomitant
medications, physical examination, vital signs and clinical laboratory tests.
osteoarthritis (OA) knee pain will be randomized to Ampion or placebo and followed for 20
weeks. The clinical effects of treatment on OA pain will be evaluated during clinic visits
at 6, 12, and 20 weeks using WOMAC® osteoarthritis Index and the Patient's Global Assessment
of disease severity (PGA). Safety will be assessed by recording adverse events, concomitant
medications, physical examination, vital signs and clinical laboratory tests.
Inclusion Criteria:
- Clinical diagnosis and radiological evidence of symptomatic osteoarthritis of the
knee
- Moderate to severe pain
Exclusion Criteria:
- Other conditions in the knee, e.g., crystal arthropathies, septic necrosis, joint
replacement, major injury within 12 months prior to screening, tense effusions
- Requires ongoing treatment with intra-articular pain medications or systemic
corticosteroids
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