A Randomized, Controlled, Double-Blind Study of a Single Intra-Articular Injection of the less than 5,000 MW Fraction of Human Albumin 5% (Ampion-Trademark) in Adults with Osteoarthritis of the Knee
A Randomized, Controlled, Double-Blind Study of a Single Intra-Articular Injection of the less than 5,000 MW Fraction of Human Albumin 5% (Ampion-Trademark) in Adults with Osteoarthritis of the Knee for the Reduction of Pain
Ampio Pharmaceuticals
60 participants
Jun 27, 2011
Interventional
Conditions
Summary
A randomized, placebo-controlled, double-blind, parallel study designed to evaluate the effect of intra-articular knee injection of Ampion (Trademark) in male or female subjects 40 years to 85 years old (inclusive) with symptomatic primary knee osteoarthritis for 6 months preceding screening. The study consists of a 3 week screening period and a 4 day study participation period. Each subject will be randomized to receive a single 10 mL knee injection of one of the following: 1. Ampion(TM) combined with lignocaine/betamethasone suspension 2. Ampion(TM) combined with betamethasone suspension 3. Saline placebo combined with lignocaine/betamethasone suspension
Eligibility
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Interventions
The eligible patient will be randomized to receive a single 10mL intra-articular injection into the study knee of one of the following treatment: 1. Ampion (Trademark) (4mL) combined with lignocaine (4mL)/betamethasone suspension (2mL) OR 2. Ampion(Trademark) (4mL), combined with betamethasone suspension (2mL) OR 3.Saline (4mL) placebo combined with lignocaine (4mL)/betamethasone (2mL) suspension Treatment 1 has Ampion combined with both betamethsone and lignocaine, whereas Treatment 2 a combination of Ampion with betamethasone but without lignocaine. Treatment 3, the Ampion is replaced with saline.
Locations(1)
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ACTRN12611000940976