EUCTR2014-004535-40-HU进行中（未招募）不适用
Prospective, single-blind, placebo-controlled, three-treatment, three-period, adaptive multi-centre Phase IIa (proof-of-concept) trial to investigate the efficacy, safety, and tolerability of Ketamine HCl PR tablets in patients with chronic non-malignant neuropathic pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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 =18 years of age at Visit 1 (Screening)
- •2. Patients with a documented history of chronic non-malignant neuropathic pain at Visit 1
- •3. Patients with a DN4 Neuropathic Pain Diagnostic Questionnaire score of =4 at Visit 1
- •4. Stable individual regular standard treatment regimen for chronic neuropathic pain, i.e. no change in drug and non-drug treatments for at least two weeks prior to Visit 1 and anticipated to remain stable until the end of the single-blind treatment phase. Use of rescue medication for neuropathic pain (including topical treatments, physical measures etc.) or any other co-medication used on an as-needed” basis that might affect pain perception or pain intensity as well as opioids as part of the regular standard treatment are not allowed in this trial.
- •5. Patients with inadequate pain control (mean current” PI on VAS >50 mm) by their current individual standard treatment regimen on at least three days of the seven-day screening phase (to be checked at Visit 2)
- •6. Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of medication, completion of subjective evaluations, attending scheduled visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing signed written informed consent at Visit 1
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Hypersensitivity or intolerance to ketamine or any of the excipients
- •2. Patients treated with any other ketamine preparation within the last month prior to Visit 1
- •3. Patients receiving opioids , regardless if as part of their individual standard treatment regimen for chronic neuropathic pain or in context with any other indication, within the last two weeks prior to Visit 1
- •4. Patients with untreated or uncontrolled arterial hypertension (sitting systolic blood pressure at rest =160 mmHg and/or sitting diastolic blood pressure at rest =90 mmHg)
- •5. History of cerebrovascular event (stroke, PRIND, TIA) within the previous six months prior to Visit 1
- •6. Known or suspected cardiac disease, especially coronary artery disease (e.g. unstable angina, congestive heart failure), tachyarrhythmia and history of myocardial infarction
- •7. Known or suspected hypovolemia or dehydration
- •8. Known or suspected hyperthyroidism or patients receiving thyroid replacement therapy within the last two weeks prior to Visit 1
- •9. Concomitant treatment with theophylline or aminophylline within the last two weeks prior to Visit 1
- •10. Long-term therapy for any chronic disease, if suspected to be unstable during the course of the trial
- •11. Regular or intermittent intake of St. John’s wort (hypericum perforatum), if not stopped at Visit 1
- •12. Other non-drug treatments such as physical measures, acupuncture, etc., if not stable since at least two weeks prior to Visit 1 or suspected to be unstable during the course of the trial
- •13. Known or suspected globe injury or increased intraocular pressure (e.g. glaucoma)
- •14. Known or suspected cranio-cerebral trauma, intracranial mass lesions, hydrocephalus or elevation of intracranial pressure within the last three months prior to Visit 1 or sequelae of previous events
- •15. Known or suspected convulsive disorder
- •16. Known or suspected acute intermittent porphyria
- •17. History or presence of moderate or severe psychiatric disorder (e.g. moderate or severe depression, schizophrenia or acute psychosis)
- •18. Known or suspected current pulmonary or upper respiratory infection
- •19. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis
- •20. History of any malignancy in the last five years; except history of in-situ cancer or basal or squamous cell skin cancer. Patients with other malignancies are eligible if they have been continuously disease free for at least five years
- •21. Known or suspected CNS depression (signs/symptoms: decreased vital signs, impaired thinking and perception, slurred speech, slowed reflexes, fatigue, decreased consciousness)
- •22. History of drug addiction or drug seeking behaviour, positive test of illicit drugs (other than medication used for individual standard treatment of pain) at Visit 1
- •23. Surgery within one month, denervation procedures within six months or neural blockade (e.g. injection of a local anaesthetic into or near to a nerve), neuromodulatory measures (e.g. TENS) or radiotherapy two weeks prior to trial Visit 1 and/or anticipated and/or scheduled during the course of the trial
- •24. Evidence of impaired hepatic function (total bilirubin, AST, ALT, GGT, or AP >3 times the upper limit of normal)
- •25. Evidence of moderate or severe renal impairment (CRCL <60 ml/min) or patients with renal failure who are on any form of dialysis
- •26. Any gastro-intestinal pathology or surgery or intractable vomiting likely to significantly influence drug absorption
- •27. Inability to swallow
研究者
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