PER-047-99已完成未知
TREATMENT OF CANCER PAIN WITH OXYGODONE OF PROLONGED RELEASE ADMINISTERED BY ORAL ROUTING EVERY TWELVE HOURS
TECNOFARMA S.A.,0 个研究点目标入组 0 人开始时间: 1999年2月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Adult male or female patients between 18 and 70 years of age with a diagnosis of cancer confirmed in histopathological form with chronic, moderate to severe cancer pain and who have had previous analgesic treatment failure with level 1 analgesics according to the scale of the WHO. Patients may be hospitalized or be in the outpatient department (the latter must qualify for 60% or more of the Kamofsky Scale just before carrying out the baseline studies
- •Patients who can swallow whole tablets (not chewed, divided or crushed).
- •Patients who accept and can sign an informed consent.
- •Patients with reason use, who respond appropriately, able to make a subjective assessment and to comply with scheduled visits during the study period.
- •Patients who know how to read and write and are able to keep a diary during their participation in the study.
- •Patients with chronic malignant pain of moderate to severe intensity, and whether the pain is somatic or nociceptive.
排除标准
- •Pregnant or lactating patients.
- •Patients who are really allergic to oxycodone or have a history of allergies or hypersensitivity to oxycodone or other opioids. This does not include patients who have experienced the common adverse effects of opioids (for example nausea, constipation, etc.) or patients whose participation in this study is contraindicated according to Appendix I
- •Patients scheduled for surgery (dental included) during the four-week study period.
- •Patients who have had a gastrostomy or colostomy.
- •Patients who have been treated with an antineoplastic (chemo or radiotherapy) in the 14 days prior to the baseline analysis or during the course of this study.
- •Patients with acute or severe bronchial asthmatic status.
- •Patients with a history of, or with active severe organ dysfunction; history of or suspected paralytic ileus; physical or psychological pathology or a laboratory diagnosis that could represent an increased risk for the patient due to exposure to the drug in this experimental study (see Appendix I) or that could alter the interpretation of this investigation.
- •Patients with severe respiratory depression.
- •Patients who are currently treated or treated with another experimental drug within 30 days prior to the start of the study.
- •Patients with a psychopathic or sociopathic background or any serious psychiatric illness.
- •Patients treated with an opioid analgesic at the beginning of the study, which can not be discontinued. (All opioid medications outside the study should be discontinued before the start of the study.)
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