NCT00399438已完成2 期
A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
研究概览
简要总结
The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire
排除标准
- •Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit
研究组 & 干预措施
1
Other
0 mg
干预措施: Placebo (Drug)
2
Other
25 mg
干预措施: BMS-562086 (Drug)
3
Other
100 mg
干预措施: BMS-562086 (Drug)
结局指标
主要结局
Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
时间窗: taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16
次要结局
- Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.(throughout the study)
- Safety(Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge)
- Blood pharmacokinetics(PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)Infection, Human Immunodeficiency VirusNCT02480881ViiV Healthcare26
已完成
1 期
The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsArthritic PsoriasisPsoriasisInflammatory Bowel DiseasesSystemic Lupus ErythematosusNCT03262727Bristol-Myers Squibb49
已完成
1 期
The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsRheumatoid ArthritisNCT03262740Bristol-Myers Squibb58
已完成
1 期
Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy ParticipantsHealthy ParticipantsNCT04249284Bristol-Myers Squibb18
已完成
1 期
A Phase 1 Drug-drug Interaction Study in Healthy VolunteersDrug-drug Interaction StudyNCT02227173Bristol-Myers Squibb20