An Observer-blinded, Dose-finding Study to Investigate the Safety, Efficacy, and Patient Preference of Lactulose for Oral Solution With Bisacodyl for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring bowel evacuation for colonoscopy.
排除标准
- •Patients with galactosemia (galactose-sensitive diet).
- •Patients known to be hypersensitive to any of the components of lactulose for oral solution.
- •Patients with a known abnormality on screening or a vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts.
- •Patients with a history of impaired renal function.
- •Patients with current or recent history of hypotension, as defined by the Investigator.
- •Patients with a history of long Q-T syndrome.
- •Patients with a history of a failed bowel preparation.
- •Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives.
- •Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery (except hemorrhoidectomy and polypectomy).
- •Patients on lactulose therapy or receiving any treatment for chronic constipation.
- •Be pregnant or nursing.
- •Patients expected to require electrocautery or argon plasma coagulation.
- •Patients less than 18 years of age.
- •Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.
- •Be otherwise unsuitable for the study, in the opinion of the Investigator.
研究组 & 干预措施
90 grams of Crystalline Lactulose
15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses
干预措施: 90 grams of Crystalline Lactulose (Drug)
135 grams of Crystalline Lactulose
15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses
干预措施: 135 grams of Crystalline Lactulose (Drug)
180 grams of Crystalline Lactulose
15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses
干预措施: 180 grams of Crystalline Lactulose (Drug)
结局指标
主要结局
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
时间窗: 10-14 hours post last consumption
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
次要结局
- Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence(1 day post last consumption)
- Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity(1 day post last consumption)
- Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant(1 day post last consumption)