EUCTR2012-004311-31-PL进行中（未招募）不适用
Randomised, double-blind, placebo-controlled, parallel-group design, multi-centre, dose-escalation phase III trial to investigate the efficacy, safety, and tolerability of Naloxone HCl PR tablets administered in a dose range of 6 mg to 48 mg once daily in patients with opioid induced constipation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 306
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. Subjects with a documented history of constipation induced or worsened by their oral, transdermal or sublingual WHO step-II or step-III opioid medication.
- •3. Requirement of laxatives to have bowel movements (BMs), or having less than 3 BMs per week when not taking laxatives, respectively.
- •4. Subjects with documented history of chronic severe non-malignant pain that requires around-the-clock opioid therapy and likely to benefit from WHO step-III opioid therapy for the duration of the trial.
- •5. Subjects with predominantly non-neuropathic pain, as determined by a DN4 Neuropathic Pain Diagnostic Questionnaire score < 4 .
- •6. Subjects 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 interviews, and compliant with protocol requirements as evidenced by providing signed 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 106
排除标准
- •1. Subjects 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 or intolerance to any active substance, i.e. oxycodone, hydromorphone, morphine, naloxone, bisacodyl, or any of the excipients of the trial medication, e.g. subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •3. Intake of naloxone or naltrexone or injection of methylnaltrexone within the past 30 days prior to Visit 1.
- •4. Subjects unwilling to discontinue pre-trial laxative medication (except fibre supplementation or bulking agents at a stable dose) and take trial specific laxative medication.
- •5. Any gastrointestinal pathology or surgery or intractable vomiting likely to significantly influence drug absorption.
- •6. Inability to swallow the trial drugs whole (e.g. due to dysphagia).
- •7. Surgery within 1 month, radiotherapy or neural blockade 2 weeks prior to Visit 1 and/or anticipated and/or scheduled during the course of the trial.
- •8. Evidence of impaired hepatic function (total bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyltransferase [GGT], or alkaline phosphatase [AP] >3 times the upper limit of normal).
- •9. Evidence of moderate or severe renal function impairment (creatinine clearance [CRCL] <60 mL/min).
- •10. Known or suspected significant hypotension, shock or severe cardiovascular disease.
- •11. Known or suspected clinically relevant endocrine disorder, such as myxoedema, not adequately treated hypothyroidism or adrenocortical insufficiency (e.g. Addison's disease)
- •12. 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, anal fissures or ulcerative proctitis).
- •13. Subjects with a confirmed diagnosis of ongoing irritable bowel syndrome.
- •14. Known or suspected acute or chronic pancreatitis or clinically relevant biliary tract disease.
- •15. Known or suspected significant prostatic hypertrophy or urethral stricture severe enough to potentially result in acute urinary retention.
- •16. 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.
- •17. Known or suspected cranio-cerebral trauma or elevation of intracranial pressure.
- •18. Known or suspected acute alcoholism, delirium tremens, or toxic psychosis.
- •19. Known or suspected severe psychiatric disorders.
- •20. History of drug addiction or drug seeking behaviour, positive test of illicit drugs at screening.
- •21. Concomitant treatment with other naloxone preparations (apart from IMP), naltrexone or methylnaltrexone preparations, other laxatives (except stable therapy with fibre supplementation or bulking agents), other medicines that can cause constipation or influence bowel motility, other opioid analgesics (including codeine-containing compounds), non-opioid analgesics taken on an as-needed basis, monoamine oxidase (MAO) inhibitors or any form of neural blockade or radiotherapy. Substantial changes in concomitant therapies with other compounds that can influence pain response such as nonsteroidal anti-inflammatory drugs (NSAIDs),
研究者
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