RecruitingPhase 1ACTRN12611000940976

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


Sponsor

Ampio Pharmaceuticals

Enrollment

60 participants

Start Date

Jun 27, 2011

Study Type

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

Sex: Both males and femalesMin Age: 40 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a single injection of a substance called Ampion directly into the knee joint can reduce pain and improve movement in people with knee osteoarthritis (wear-and-tear arthritis). Ampion is derived from human albumin (a natural protein in blood). Participants will receive one of three types of injections and will be followed for 4 days to check for effects and side effects. You may be eligible if: - You are between 40 and 85 years old - You have been diagnosed with moderate knee osteoarthritis (Grade II or III) for at least 6 months - You are able to walk independently - You are able to give written informed consent - You are willing to avoid pregnancy during the study (if applicable) You may NOT be eligible if: - You are pregnant or breastfeeding - You have had a knee injection, surgery, or arthroscopy recently - You have inflammatory arthritis, crystal arthritis, fracture, or severe bone loss - You have a known allergy to human albumin - You have been treated with steroids, anticoagulants, or NSAIDs recently Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 lignocain

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)

Australia

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ACTRN12611000940976


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