ACTRN12611000940976
招募中
1 期
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
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoarthritis of the knee
- 发起方
- Ampio Pharmaceuticals
- 入组人数
- 60
- 状态
- 招募中
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Male or female, 40 years to 85 years old (inclusive), fully ambulatory, willing to sign informed consent.
- •2\.Symptomatic index knee osteoarthritis greater/equal to 6 months prior to screening with Kellgren Lawrence Grade II or III.
- •3\.Symptoms in the index knee for at least 6 months preceding screening.
- •4\.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.
- •5\.Is able to provide written informed consent to participate in the study in accordance with local regulations, and is not under any guardianship provision.
- •6\.Is willing and able to comply with all study requirements and instructions of the site study staff.
排除标准
- •1\.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.
- •2\.A history of allergic reactions to albumin (reaction to non human albumin such as egg albumin is not an exclusion criteria).
- •3\.A history of allergic reactions to excipients in 5% human albumin (N\-acetyltryptophan, sodium caprylate).
- •4\.Any intra\-articular or local periarticular injection, injection or surgery to the index knee during the 6 months prior to screening.
- •5\.Operative arthroscopy within 3 months of screening.
- •6\.Surgical procedure to the index knee other than arthroscopy within 12 months of participation in the trial.
- •7\.Any investigational knee products within 12 months of participation in the trial.
- •8\.Kellgren Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
- •9\.Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
- •10\.Isolated patella\-femoral syndrome or chondromalacia.
结局指标
主要结局
未指定
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