A Randomized, Double Blind, Double-dummy, 2-treatment, 2-period Crossover Comparison of Sennosides and Polyethylene Glycol in Treatment of Opioid-induced Constipation in Outpatients With Cancer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Bowel Performance Scale (BPS)
研究概览
简要总结
This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.
详细描述
One group will be started on a bowel protocol of escalating doses of sennosides, plus a dummy polyethylene glycol (lactose), and the other will receive dummy sennosides capsules (lactose) plus polyethylene glycol, with the same dosing protocol. After three weeks of one active treatment the patients will switch to the alternate active product and dummy preparation. The total duration for the study will be 6 weeks for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind using a dummy alternate treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (18 years and above) with diagnosis of cancer.
- •Patient requires treatment or prevention of constipation.
- •Patient is able to communicate effectively with staff.
- •Expected prognosis more than 12 weeks.
- •On or starting opioid therapy
排除标准
- •Patient unable to take oral medication.
- •Allergy or previous intolerance to PEG or sennosides.
- •Lactose intolerant.
- •Contraindication to PEG or sennosides.
- •Known or suspected bowel obstruction or ileus.
- •Colostomy or ileostomy.
- •Inflammatory bowel disease.
- •Hospitalisation expected within the study period.
- •Patient unable to complete the study diary in English.
研究组 & 干预措施
PEG then Senna
PEG in stepped bowel protocol
干预措施: PEG then Senna (Drug)
Senna then PEG
Stepped bowel protocol with Senna then PEG
干预措施: Senna then PEG (Drug)
结局指标
主要结局
Bowel Performance Scale (BPS)
时间窗: Last 18 days of each 21 day study period
Mean values of Number of Days with Satisfactory Bowel Movements Per Days of Treatment across time by treatment, derived from the mixed effects Poisson regression model. If the BPS rating on a day was -1, 0 or +1, the patient's bowel movement on that day was deemed to be satisfactory.
次要结局
- Time (in Days) to Attain an Ideal BPS Score of Goal(3 weeks (ascertained at the end of period 1))
- Rectal Measures(Last 18 days of each 21 day study period)
- Incidence of Cramps(Last 18 days of each 21 day study period)
- Patient Preference(end of study (6 weeks))
研究者
Pippa Hawley
Principal Investigator
British Columbia Cancer Agency