NCT01109511已完成4 期
A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy
Ullevaal University Hospital1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2010年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Constipation in subjects with postoperative pain
研究概览
简要总结
Objectives:
Primary objective:
- To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is superior to the treatment with OxyPR with regards to constipation in subjects with postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1 week postoperatively.
The secondary objectives:
- Analgesic effect (including registration during the first 24 hrs)
- To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72 hrs)
- Frequency of nausea and vomiting
- Frequency of other adverse events
- Appetite
- Mobilization
The exploratory objectives:
- Overall patient satisfaction at 24, 72 hrs and 1 week
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 18 -70 years
- •Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
- •Subjects willing and able to participate the study and have provided informed consent form -
排除标准
- •Previous recent or regular opioid use (WHO step I pain treatment allowed)
- •Any situation where opioids are contraindicated.
- •Any history of moderate to severe hepatic impairment.
- •Any history of severe respiratory depression with hypoxia and/or hypercapnia
- •Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
- •Subjects with evidence of non-opioid induced paralytic ileus
- •Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
- •Subjects with evidence of Addison's disease (adrenal cortical insufficiency), toxic psychosis,cholelithiasis, prostate hypertrophy, alcoholism, delirium, pancreatitis, hypotension, hypertension, pre-existing cardiovascular diseases, head injury (due to the risk of increased intracranial pressure), epileptic disorder or predisposition to convulsions, or patients taking MAO inhibitors.
- •Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
- •Active alcohol or drug abuse and/or history of opioid abuse.
- •Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
- •Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
研究组 & 干预措施
oxycodone+naloxone
Active Comparator
干预措施: naloxone (Drug)
oxycodone+naloxone
Active Comparator
干预措施: oxycodone (Drug)
Control
Active Comparator
Oxycodone alone without naloxone
干预措施: oxycodone (Drug)
结局指标
主要结局
Constipation in subjects with postoperative pain
时间窗: 3 days
次要结局
未报告次要终点
研究者
Johan C Ræder
Professor
Oslo University Hospital
研究点 (1)
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