NL-OMON44014已完成不适用
A randomized, double-blind, placebo-controlled study to investigate the effects of an 8-week recombinant human erythropoietin (NeoRecormon) treatment on well-trained cyclists and their cycling performance. - Erythropoetine effects on cycling performance.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Well-trained (as determined by cycling history and maximal power output >4 W/kg) male subjects, 18 to 50 years old (inclusive);
- •2. Subjects must be healthy / medically stable on the basis of clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed at screening, including exercise ECG.
- •3. Each subject must sign an informed consent form prior to the study. This means the subject understands the purpose of and procedures required for the study.
排除标准
- •1. Any clinically significant abnormality, as determined by medical history taking and physical examinations, obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety.
- •2. Unacceptable known concomitant diagnoses or diseases at baseline, e.g., known cardiovascular, pulmonary, muscle, metabolic or haematological disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc.
- •3. Unacceptable concomitant medications at baseline, e.g., drugs known or likely to interact with the study drugs or study assessments.
- •4. Unacceptable potential cycling performance enhancing medications at baseline, e.g. Erythropoiesis-stimulating agents, Anabolic Androgenic Steroids, Growth Hormone, Insulin, IGF-I and Beta-Adrenergic Agents or methods, e.g. altitude tents.
- •5. Blood transfusion in the past three months.
- •6. Loss or donation of blood over 500 mL within three months.
- •7. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
- •8. Known hypersensitivity to the treatment or drugs of the same class, or any of their excipients.
- •9. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- •10. Positive urine drug test at screening
- •11. Positive alcohol breath test at screening
- •12. Haemoglobin (Hb) concentration > 9.8 mmol/l at screening.
- •13. Hb concentration < 8 mmol/l at screening.
- •14. Haematocrit (Ht) * 48% at screening.
- •15. Being subject to WADA*s anti-doping rules, meaning being a member of an official cycling union or other sports union for competition (such as the KNWU) or participating in official competition during the study.
- •16. Positive results from serology at screening (except for vaccinated subjects or subjects with past but resolved hepatitis)
- •17. Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- •18. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
研究者
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