Lubiprostone as a Treatment for Constipation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks
研究概览
简要总结
Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following:
- Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)
- Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)
- Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-85 years
- •Diagnosis of Parkinson's disease
- •Constipation as defined by the Rome III committee
- •BSFS of more or equal to 1 and less or equal to 3
- •Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
- •All women subjects will be post menopausal or surgically sterile.
排除标准
- •Known hypersensitivity reaction to Amitiza ( Lubiprostone)
- •Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
- •Renal dysfunction with creatinine clearance less than 15 ml/min
- •Abnormal liver enzymes or history of chronic liver disorder
- •History of bowel obstruction, , or abdominal adhesions .
- •Abnormal Colonoscopy ( obstructive lesions within the colon)
- •Inability to give informed consent
研究组 & 干预措施
Patients
干预措施: Lubiprostone (Drug)
结局指标
主要结局
Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks
时间窗: up to 6 weeks
The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).
次要结局
- Average Number of Spontaneous Bowel Movements (SBM) Per Week(up to 6 weeks)