EUCTR2009-011525-13-GB进行中（未招募）不适用
Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients attending a Specialist Clinic - Phase II Open-Label Pilot Study of V3381 in Chronic Cough
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Male or female 18-75 years of age
- •Females must be of non child-bearing potential (ie. Surgically sterilised or >1 year post-menopause). Male subjects who are sexually active with a female partner of child-bearing potential must agree to use a barrier method of contraception for the duration of the study,
- •Chronic Cough ( > 8 weeks)
- •Normal Chest X-ray
- •Normal Lung Function
- •Idiopathic or treatment resistant cough (defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation (idiopathic) or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip (treatment-resistant)).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Recent upper respiratory tract infection (<4 weeks)
- •Pregnancy/breast-feeding
- •Current smokers or ex-smokers with <6 months abstinence or cumulative history of >10 pack years
- •Current treatment with ACE inhibitors.
- •Drug or alcohol abuse
- •Uncontrolled hypertension (i.e., >140/90 mmHg despite adequate medical therapy).
- •Any cardiovascular condition that would be a contra-indication to the use of sympathomimetic amines (e.g. active angina).
- •Any clinically significant neurological disorder
- •Prior renal transplant, current renal dialysis.
- •Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study.
- •Increased risk of seizures (defined as a history of seizure disorder, family history of seizures and history of head trauma that resulted in loss of consciousness or concussion).
- •Any malignancy in the past 2 years (with the exception of basal cell carcinoma).
- •Use of opioids, anticonvulsants, antidepressants (particularly MAO inhibitors). Patients currently taking drugs in these classes for chronic cough may have them discontinued prior to entry into the study. Selective serotonin reuptake inhibitors should be discontinued at least 4 weeks prior to study; all other prohibited medications should be discontinued 2 weeks prior to study. Patients should not be taking NMDA-receptor antagonists or sympathomimetics during the study period.
- •Any clinically significant abnormal laboratory test result(s).
- •Serum creatinine laboratory value greater than 1.5 x upper limit of normal (ULN) reference range (after adjustment for age) or estimated creatinine clearance <60 mL/min.
- •Total bilirubin greater than upper limit of normal reference range (with the exception of Gilbert’s Syndrome) and/or alanine transaminase (ALT) >1.5 times upper limit of normal reference ranges (after adjustment for age).
研究者
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