Effects of A3309, an Ileal Bile Acid Transport Inhibitor, on Gastrointestinal and Colonic Motor Functions in Female Patients With Functional Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Colonic Transit at 24 Hours
研究概览
简要总结
This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation.
详细描述
Study period Estimated date of first patient enrolled: January 2010 Study design This is a single-center, randomized, parallel group, double-blind, placebo-controlled, dose response, pharmacodynamic and pharmacokinetic study evaluating the effects of A3309 on gastric, intestinal and colonic transit in patients with functional constipation. Doses of 10 or 20 mg A3309 or matching placebo will be administered orally once daily for fourteen (14) consecutive days.
Aim To assess the dose related effects of A3309 on small bowel and overall colonic transit and bowel function in patients with functional constipation.
Number of patients planned Twelve completed female patients with functional constipation in each treatment group for a total of 36 patients.
Diagnosis and main eligibility criteria Female patients with diagnosed functional constipation will be recruited from the local community by public advertisement placed within areas of Mayo Clinic or by a targeted mailing of an informational letter.
Methodology Patients with functional constipation will be screened for eligibility and informed about the study during pre-screening dialogue and also at the initial Visit 1 screen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A3309 15 mg
Patients randomized to this arm received one oral tablet daily of 15 mg A3309 for a period of 14 consecutive days.
干预措施: A3309 (Drug)
A3309 20 mg
Patients randomized to this arm received one oral tablet daily of 20 mg A3309 for a period of 14 consecutive days.
干预措施: A3309 (Drug)
Placebo
Patients randomized to this arm received one oral tablet daily of a matching placebo for a period of 14 consecutive days.
干预措施: placebo (Drug)
结局指标
主要结局
Colonic Transit at 24 Hours
时间窗: 24 hours post-radiolabeled meal
Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Colonic transit was measured by quantification of radioactive counts via abdominal scintiscans. Overall colonic transit was computed as the colonic geometric center (GC), which is the weighted average of counts in the different colonic regions (ascending, transverse, descending, rectosigmoid and stool), respectively numbered 1 to 5. At any time point, the GC equals the proportion of counts in each colonic region multiplied by its weighting factor: (%ACx1+%TCx2+%DCx3+%RSx4+%stoolx5)/100. As such, a higher GC reflects faster colonic transit. A GC of 1 implies all the isotope is in the ascending colon and a GC of 5 implies all the isotope is in the stool.
次要结局
- Colonic Filling(6 hours post-radiolabeled meal)
- Gastric Emptying , T1/2(post-treatment, approximately 12-14 days)
- Colonic Transit at 8 Hours(8 hours post-radiolabeled meal)
- Treatment Effectiveness of A3309(Day 14)
- Ascending Colon Emptying t 1/2(post-treatment, approximately 12-14 days)
- Stool Frequency(14 days)
- Colonic Transit at 48 Hours(48 hours post-radiolabeled meal)
- Stool Consistency(14 days)
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic