EUCTR2011-004471-37-SI进行中（未招募）不适用
Randomised, double-blind, cross-over Phase III study to investigate the efficacy and safety of hydromorphone after once daily administration of Hydromorphone HCl PR tablets XL in comparison to twice daily administration of Palladon® retard capsules in patients with chronic severe cancer or non-cancer pain.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
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.
- •2.Patients with chronic severe cancer or non-cancer pain.
- •3.Patients with predominantly non-neuropathic pain (assessed by the DN4 Neuropathic Pain Diagnostic Questionnaire).
- •4.Patients with documented history of chronic severe pain that requires around-the-clock opioid therapy and are likely to benefit from WHO step III opioid therapy for the duration of the study.
- •5.Women of childbearing potential agree to undergo pregnancy tests.
- •6.Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study, 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.
- •7.For inclusion in double-blind treatment phase adequate analgesia (mean current pain intensity per day >0 mm and =40 mm on VAS) prior to randomisation for at least three consecutive days.
- •8.For inclusion in double-blind treatment phase stable analgesic requirements of at least 8 mg hydromorphone HCl per day prior to randomisation for at least three consecutive days (stable maintenance dose of hydromorphone; =2 doses of rescue medication per day), tolerable AEs.
- •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 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •1.Patients with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
- •2.Hypersensitivity to hydromorphone or any of the excipients of the study medication.
- •3.Patients requiring less than 8 mg or more than 32 mg hydromorphone HCl per day at the start of the double-blind treatment phase.
- •4.Surgery within 1 month prior to study start or anticipated or scheduled surgical intervention during the study.
- •5.Intravenous chemotherapy or radiotherapy for pain alleviation or neural blockade within 2 weeks prior to study start or anticipated or scheduled during the course of the study.
- •6.Known or suspected significant hepatic impairment (hepatic transaminases >3 times the upper limit of normal).
- •7.Known or suspected severe renal impairment (CRCL <30 ml/min) or patients with renal failure who are on any form of dialysis.
- •8.Known or suspected significant circulatory disturbance, hypotension, or circulatory shock.
- •9.Known or suspected clinically relevant endocrine disorder, such as myxoedema, not adequately treated hypothyroidism or adrenocortical insufficiency (e.g. Addison's disease).
- •10.Known or suspected clinically significant bowel disease (e.g. paralytic ileus, significant impairment of bowel motility severe enough to potentially result in ileus, obstructive or inflammatory bowel disease).
- •11.Known or suspected acute or chronic pancreatitis or biliary tract disease.
- •12.Any gastro-intestinal pathology or surgery or intractable vomiting likely to significantly influence drug absorption.
- •13.Inability to swallow the study drugs whole (e.g. due to dysphagia).
- •14.Known or suspected significant prostatic hypertrophy or urethral stricture severe enough to potentially result in urinary retention.
- •15.Known or suspected CNS depression (signs/symptoms: decreased vital signs, impaired thinking and perception, slurred speech, slowed reflexes, fatigue, decreased consciousness), coma, or convulsive disorder.
- •16.Known or suspected elevation of intracranial pressure.
- •17.Known or suspected acute alcoholism, delirium tremens, or toxic psychosis.
- •18.History of drug addiction or drug seeking behaviour.
- •19.Concomitant treatment with MAO inhibitors.
- •20.Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to practice adequate contraceptive measures. Reliable methods for women are hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence.
- •21.Any other condition of the patient that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient's safety (e.g. risk of suicide), compliance or adherence to protocol requirements.
- •22.Previous enrolment in this study or participation in any other drug investigational trial within the past 30 days (or five half-lives whichever is longer) prior to enrolment.
- •23.Persons committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
研究者
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