EUCTR2014-000306-36-GB进行中（未招募）不适用
A double-blind, randomised, placebo-controlled, crossover study to assess the efficacy of XEN D0501, a TRPV1 antagonist, in reducing the frequency of cough in patients with chronic idiopathic cough
Xention Limited0 个研究点开始时间: 2014年3月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 patients aged 18 years or over with chronic idiopathic cough, defined as:
- •a) Attending a specialist cough clinic with a history of cough for more than 8 weeks
- •b) Idiopathic cough (defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation) or treatment-resistant cough (defined as a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip).
- •2. Normal chest radiography i.e., chest X-ray or CT thorax, prior to the study (within 12 months of Visit 1)
- •3. Normal spirometry (i.e. forced expiratory volume in 1 second [FEV1] >80% predicted)
- •4. Day time cough frequency >1.5 coughs/hour (from 24-hour cough monitor at Visit 3),
- •5. Emax from capsaicin challenge >10 coughs (from challenge cough monitor at Visit 3),
- •6. Women must be of non-child bearing potential.
- •a) Non-child bearing potential is defined as amenorrhoeic for at least 1 year AND, if aged under 60 years, have serum follicle stimulating hormone [FSH] level of at least 30 IU/L or have undergone a hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable). Women who are taking hormone replacement therapy (HRT) do not have to have FSH assessments, but the amenorrhea (before starting HRT) must have been naturally (spontaneously) occurring and have been accompanied by an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms).
- •b) If female partners of male patients are of childbearing potential, the patient must be willing to use contraception (e.g. condoms plus spermicide) AND their female partner must also be using contraception (e.g. hormonal or intra-uterine device). This double contraception must be used from the first dose of study drug until at least 90 days after the last dose of study drug.
- •7. Written informed consent.
- •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 17
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Body Mass Index (BMI) >35 kg/m2,
- •2. Current smokers or patients with urine cotinine =500 ng/mL,
- •3. Ex-smoker of <6 months,
- •4. Cumulative smoking history of =10 pack years
- •5. Upper respiratory tract infection within the last 6 weeks prior to randomisation (Visit 3),
- •6. Feverish illness within the last 1 week prior to randomisation (Visit 3),
- •7. Concomitant medications which may influence cough or interact with study drugs e.g. opioids, gabapentin, pregabalin, amitriptyline, ACE inhibitors, potent CYP3A4 inhibitors (such as ketoconazole, clarithromycin or HIV protease inhibitors) and systemic corticosteroids (use of local injectable, topical or inhaled corticosteroids is permitted),
- •8. Patients with concomitant conditions which may influence the cough reflex or the patient’s ability to participate in the study e.g. diabetes, cerebrovascular disease, Parkinson’s disease,
- •9. History of drug or alcohol dependency or abuse within approximately the last year prior to screening (Visit 1),
- •10. Regular alcohol consumption; >21 units/week for males, or >14 units/week for females, during the study (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine),
- •11. Any known allergy to the study drugs,
- •12. Pregnant and/or lactating women,
- •13. History or evidence of urinary retention, bladder outlet obstruction or benign prostatic hypertrophy,
- •14. Any clinically significant abnormalities in haematology or clinical biochemistry tests prior to randomisation (Visit 3),
- •15. Serum alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) greater than twice the upper limit of normal (ULN) at Visit 1,
- •16. Total serum bilirubin >1.5x ULN at Visit 1,
- •17. History of any kind of cancer within the last 5 years unless non-invasive, in remission and approved in writing by Sponsor,
- •18. Evidence of any other clinically significant disease or condition which in the opinion of the investigator would preclude the patient’s participation in this study,
- •19. QTcF value at Visit 1 (mean) of >450 msec (males) or >470 msec (females),
- •20. Patients with uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at Visit 1 (mean) or Visit 2,
- •21. Received investigational or marketed products as part of any other clinical study within 30 days (or 5 half-lives whichever is longer) prior to screening (Visit 1),
- •22. Patient is unable or unwilling to co-operate with the study procedures.
研究者
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