EUCTR2007-004654-81-GB进行中（未招募）不适用
A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients
相关药物
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. The patient has Parkinson’s disease, with a score of >2 on the salivation section of
- •2. The patients’ anti-Parkinsonian medication is anticipated to remain constant (in terms of drugs, doses and timing) throughout the study period.
- •3. The patient is aged 18 to 75 years.
- •4. The patient is capable of giving informed consent and complying with the restrictions and requirements of the protocol.
- •5. The patient is available to complete the study.
- •6. The patient is registered with a General Practitioner (GP).
- •7. A signed and dated consent form has been obtained from the patient in accordance with ICH GCP.
- •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
- •1. As a result of the medical screening process, the study physician considers the patient unfit for the study.
- •2. The patient is taking anticholinergic or a2 agonist medication.
- •3. The patient is taking medication that affects acetyl choline levels e.g. tricyclic
- •antidepressants.
- •4. The patient has a history or presence of bladder outflow obstruction.
- •5. The patient has a hypersensitivity to oxybutynin or any component.
- •6. The patient has a hypersensitivity to clonidine hydrochloride or any component.
- •7. The patient has a history or presence of Myasthenia gravis.
- •8. The patient has a history of narrow angle glaucoma or shallow anterior chamber.
- •9. The patient has a history or presence of gastrointestinal obstruction including paralytic ileus and intestinal atony or gastrointestinal motility disorders.
- •10. The patient has a history or presence of toxic megacolon or severe ulcerative colitis.
- •11. The patient has documented autonomic neuropathy, hepatic or renal impairment,
- •12. The patient has presence of any clinically significant abnormality, in the opinion of the Investigator, on ECGs (including patients with baseline QTc > 430 msecs - males, > 450 msecs female) at screening.
- •13. The patient has a history or presence of severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree.
- •14. The patient has a history or presence of hyperthyroidism, congestive heart failure, coronary heart disease, cardiac arrhythmias, tachycardia, current uncontrolled
- •hypertension, significant postural hypotension or urinary retention.
- •15. The patient has current active depression, Raynaud’s disease or other peripheral
- •vascular occlusive disease.
- •16. The patient has a history of drug or other allergy that contraindicates his/her
- •participation.
- •17. The patient has participated in a study with a new molecular entity within 4 months, or any other drug trial within 3 months of dosing with the investigational product or placebo.
- •18. The patient has donated a unit of blood (450 mL) in the 3 months prior to dosing or intends to donate in the month after the last scheduled study visit.
- •19. The subject has a history of drug abuse.
- •20. The patient, if a pre menopausal female, is pregnant or at risk of becoming pregnant.
研究者
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