EUCTR2011-004033-13-GB进行中（未招募）不适用
A Phase 2 open label biomarker study of angiotensin II type 2 receptor antagonist EMA401 for the treatment of pain in patients with chemotherapy-induced peripheral neuropathy. - A study of EMA401 and biomarkers in the treatment of pain due to nerve damage following chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Are able to give voluntary written informed consent to participate in the study.
- •2. Are 18 to 80 years old inclusive.
- •3. Have previously received taxane and/or platinum based chemotherapy for any type of cancer and are not expected to receive further chemotherapy for the study duration.
- •4. Show signs and symptoms of sensory peripheral neuropathy of the lower limbs which have been clinically stable for at least 8 weeks prior to Screening.
- •5. Have a history of spontaneous pain in the lower limbs for at least 8 weeks prior to Screening.
- •6. Have an average evening Numerical Pain Rating Scale (NPRS) score of =4 for spontaneous pain in the lower limbs across seven consecutive days during the Screening period.
- •7. Are female of non-child-bearing potential (i.e. either surgically sterilised or one year post-menopausal), or if of child-bearing potential, must have used adequate contraceptive precautions for 30 days prior to Screening, and must agree to use two approved methods of contraception for the duration of the study and for one month after administration of the last dose of study medication
- •Are male and agree to use two approved methods of contraception for the duration of the study and until one month after administration of the last dose of the study medication.
- •8. Are able to read and understand English.
- •9. Have a telephone.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Are pregnant or breast-feeding.
- •2. Do not and cannot comply with the protocol concomitant medication restrictions.
- •3. Have participated in an investigational medical product study within the 3 months prior to Day 1.
- •4. Exposure to more than 3 new chemical entities within the 12 months prior to Day 1.
- •5. Have previously received EMA401.
- •6. Are known to be allergic to EMA401 or any of the excipients.
- •7. Have a history or evidence of any other clinical neuropathy.
- •8. Have any other pain condition or injury that may confound the self-evaluation of pain due to peripheral neuropathy.
- •9. Have any history of clinically significant cardiac arrhythmias or the presence of clinically significant abnormalities on electrocardiogram (ECG) at screening.
- •10. Resting supine blood pressure > 165/95mmHg.
- •11. Have a resting pulse rate >100 or <50 beats per minute (bpm) on two consecutive measurements at least 10 minutes apart.
- •12. Have a calculated creatinine clearance (using Cockroft and Gault formula) of less than 50 mL/min at Screening.
- •13. Have serum aspartate transaminase (AST), gamma glutamyl transaminase (GGT) or alanine transaminase (ALT) levels greater than 3.0 x the upper limit of normal or have total bilirubin concentrations greater than 2.0 x the upper limit of normal at Screening.
- •14. History of or current hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV) infection.
- •15. Other than the condition under study, have a history of or current active medical condition including allergic, skin, cardiovascular, psychiatric disease, drug or alcohol abuse, or laboratory finding, that in the opinion of the investigator precludes participation in the study, or may interfere with the study objectives / results.
- •16. Patients with pacemaker or implanted brain or cord stimulators.
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