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
Inclusion Criteria7
- Male or female, 40 years to 85 years old (inclusive), fully ambulatory, willing to sign informed consent.
- Symptomatic index knee osteoarthritis greater/equal to 6 months prior to screening with Kellgren Lawrence Grade II or III.
- Symptoms in the index knee for at least 6 months preceding screening.
- Because of the unknown effects of AmpionTM, women should avoid becoming pregnant during the course of this study if you become pregnant you will have to withdraw from the trial and your medical progress will be carefully followed. These precautions are necessary because the information on the effects on the unborn or new born baby of drugs like AmpionTM, is still very limited. Your own doctor, as well as the study coordinator should be able to assist you if you have any questions about the need to avoid pregnancy.
- Because of the unknown effects of AmpionTM, on sperm and possibly on foetus, men should avoid any possibility of fathering a child during the course of this trial. If your partner does become pregnant you should notify the study coordinator and their medical progress will be monitored. These precautions are necessary because the information on the effects on the unborn or new born baby of drugs like AmpionTM, is still limited. Your own doctor, as well as the study coordinator, should be able to assist you if you have any questions about the need to avoid emitting sperm that might result in pregnancy.
- Is able to provide written informed consent to participate in the study in accordance with local regulations, and is not under any guardianship provision.
- Is willing and able to comply with all study requirements and instructions of the site study staff.
Exclusion Criteria25
- As a result of medical review and screening investigation (including electrocardiogram (ECG) and laboratory tests), the Principal Investigator considers the patient unfit for the study.
- A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
- Any intra-articular or local periarticular injection, injection or surgery to the index knee during the 6 months prior to screening.
- Operative arthroscopy within 3 months of screening.
- Surgical procedure to the index knee other than arthroscopy within 12 months of participation in the trial.
- Any investigational knee products within 12 months of participation in the trial.
- Kellgren Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
- Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
- Isolated patella-femoral syndrome or chondromalacia.
- Any other disease or condition interfering with the free use and evaluation of the index knee for the duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis).
- Major injury to the index knee within the 12 months prior to screening.
- Severe hip osteoarthritis ipsilateral to the index knee.
- Any pain that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
- Any pharmacological or non-pharmacological treatment started or changed during the
- weeks prior to randomization or likely to be changed during the duration of the study.
- Use of the following medications:
- a. Any topical treatment on osteoarthritis knees within 48 hours prior to randomization.
- b. All analgesics and NSAIDs except paracetamol within 48 hours prior to randomization
- c. Anticoagulant therapy for 48 hours prior to randomization
- d. Any systemic steroid treatments within 14 days prior to randomization
- e. All immunosuppressives within a period of 5 times the drug’s half life prior to randomization
- Use of corticosteroids greater than 10 mg prednisolone equivalent per day during the 30 days prior to randomization.
- Any albumin treatment in the 3 months before randomization.
- Female subjects who are pregnant or lactating.
- Female subjects of childbearing potential who have a positive pregnancy test on Day 1 prior to treatment.
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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