EUCTR2016-004979-49-GB进行中（未招募）1 期
A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF THREE DOSES OF ORVEPITANT IN SUBJECTS WITH CHRONIC REFRACTORY COUGH
eRRe Therapeutics Ltd.0 个研究点目标入组 292 人开始时间: 2017年4月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 292
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. Male and female subjects =18 years of age
- •2. Able to understand and comply with the requirements of the study and sign Informed Consent forms
- •3. Diagnosis of CRC or unexplained cough for at least 1 year prior to Screening (see American College Chest Physicians/British Thoracic Society [ACCP/BTS]guidelines Section 17)
- •4. An awake average cough frequency of =10 coughs/hour, as assessed using an ACM during the Screening period (note, the ACM will be worn for a 24-hour period and the average waking cough frequency determined)
- •5. Females must be non-pregnant and non-lactating with no intention of pregnancy during study treatment
- •6. Women of child-bearing potential (WOCP) (i.e. not surgically sterilised or post-menopausal*) must have a negative blood serum pregnancy test performed at the Screening visit and agree to use two methods of birth control, one of which must be a barrier method (note: the double barrier method is not considered acceptable) for the duration of participation in the study.
- •* Post-menopausal is defined as >1 year since the last menstrual period for women >55 years of age or >1 year since their last menstrual period and have an FSH level in the menopausal range for women <55years of age.
- •Acceptable methods of birth control are:
- •a. Surgical sterilization of the subject’s male partner (vasectomy with documented azoospermia) if he is the sole partner of that subject
- •b. Established hormonal contraception (implantable, patch, oral or intramuscular [IM]) administered for at least one month prior to IMP administration and to continue for at least 4 weeks after the last dose of IMP
- •c. An intrauterine device (IUD) or intrauterine system (IUS) with failure rate of less than 1% per year inserted by qualified physician at least one month prior to IMP administration and to remain in place for at least 4 weeks after the last dose of IMP
- •d. Barrier methods such as male condom or cap, diaphragm or sponge with spermicide
- •7. Male subjects and their partners of child-bearing potential must use two methods of acceptable birth control, one of which must be a barrier method; male subjects must make no donation of sperm from Screening until 90 days after the last dose of IMP
- •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 172
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Subjects with recent respiratory tract infection <4 weeks prior to Screening
- •2. Females who are breast feeding or pregnant
- •3. Current smokers or ex-smokers with <6 months’ abstinence prior to Screening
- •4. Treatment with Angiotensin Converting Enzyme inhibitors within 3 months of Screening
- •5. A history of drug or alcohol abuse within 12 months of Screening
- •6. Both FEV1 <80% predicted and FEV1/FVC ratio < 0.7, measured at Screening using spirometry
- •7. History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease
- •8. Evidence of uncontrolled hypertension at Screening or Baseline (As guidance, systolic >160 mm Hg or diastolic >90 mmHg should result in further evaluation which may include repeat measurements after a period of rest)
- •9. Recent myocardial infarction within 1 year prior to Screening, or history of congestive cardiac failure
- •10. Any clinically significant abnormalities on 12-lead ECG at Screening or Baseline/Day 1
- •11. Subjects with prior renal transplant, current renal dialysis, or history of renal tubular acidosis
- •12. Any clinically significant neurological disorder
- •13. Any clinically significant or unstable medical or psychiatric condition that would interfere with the subject's ability to participate in the study
- •14. Subjects with a prior medical history of or an increased risk of seizures (except febrile seizures in infancy), or who have a history of recent head trauma within the last 6 months prior to Screening that resulted in a loss of consciousness or concussion
- •15. Any malignancy in the past 5 years unless noninvasive and in remission (disease-free for >5 years prior to Screening) and written approval has been obtained from Sponsor, with the exception of skin cancers not including malignant melanoma
- •16. Any clinically significant abnormal laboratory test result(s) measured at Screening (The investigator should judge the clinical relevance of any abnormal laboratory parameters in the context of the subject’s current and past medical history and any know contributing factors)
- •17. Inability to comply with the use of prohibited and allowed medications as described below:
- •a. The use of opioids, dextromethorphan, gabapentin, pregabalin, baclofen, antihistamines or tricyclic antidepressants for treatment of cough is not allowed throughout the study. Subjects must have discontinued these drugs at least 1 month prior to Screening. Subjects may, however, be permitted to continue to use these drugs if they have been prescribed solely for the management of another disorder
- •b. The use of other drugs taken solely for the treatment of cough is also prohibited from at least 1 month prior to Screening
- •c. Concomitant respiratory medication (other than for management of cough) is allowed, but subjects must be stable on such medication and take it for the duration of the study
- •d. Use of digoxin is not allowed from Screening until 1 week after the last dose of IMP
- •e. Use of known CYP3A4 substrates with a narrow therapeutic range is not allowed from Screening until 1 week after the last dose of IMP (including but not limited to alfentanil. cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus)
- •f. Use of strong or moderate inhibitors of CYP3A4 is not allowed from Screening until 1 week after the last dose of IMP (including but not limited to clarithromycin, erythromycin, grape
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