ACTRN12609000209291招募中3 期
Randomised, placebo-controlled,double-blind, cross-over study of the efficacy of sustained-release low dose morphine in the subjective sensation of dyspnoea due to maximally treated primary pulmonary hypertension in opioid naive participants.
Flinders University - Department of Palliative and Support Services0 个研究点目标入组 40 人开始时间: 2009年4月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •English speaking. Participants over the age of 18.Dyspnoea secondary to maximally medically treated primary pulmonary
- •hypertension as assessed by the person’s respiratory physician. New York Heart Association heart failure grade III or IV.Renal function - calculated creatinine clearance >10mmol/l. Haemoglobin > 10 g/dl, or treating clinician has reviewed the haemoglobin result and confirmed that patient is on maximal treatment.On stable oxygen - no changes to prescription in the last 7 days. On stable medications – no changes to prescription medications in the last 7 days. Able to complete participant diary.Willing and able to give informed consent.
排除标准
- •Taking regular opioid medications.True adverse reaction(s) to morphine previously. Known hypersensitivity to any of the morphine sulphate capsule components. History of central hypoventilation syndrome.
- •Use of monoamine oxidase inhibitor(s) (MAOIs) in the last 2 weeks or proposed use during the study.Australian Karnofsky Modified Performance Status (modified AKPS) < 50. Acutely confused (Nursing Delirium Assessment Scale score > 0 at baseline).Cognitive impairment (Mini-Mental State Examination < 24 at baseline). Uncontrolled nausea or vomiting.
- •.Gastrointestinal obstruction.Pregnancy, risk of pregnancy or breast feeding mothers.
- •Past history of significant illicit opioid misuse.
研究者
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