NCT00102310已完成2 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group, Dose Ranging Study of YM443 in Subjects With Functional Dyspepsia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 59
研究概览
简要总结
The primary objective of this study will be to characterize the dose response profile of YM443 in subjects with functional dyspepsia (FD) to enable the selection of doses for the Phase 3 clinical trial.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to read and write in English.
- •Written informed consent has been obtained.
- •18-75 years of age on the day the Informed Consent Form is signed.
- •Men or women.
- •Females, not pregnant, lactating or likely to become pregnant.
- •Abdominal ultrasound and/or upper endoscopy findings that are judged as not clinically significant by the Investigator during Screening or within 4 weeks prior to Screening.
- •Symptoms of FD at Visits 1 and 4 as defined by Rome II criteria.
- •Subjects with a positive H. pylori breath test at Screening may be included in the study.
- •Subjects with pH-metry results at Screening indicative of reflux may be included in the study.
- •ECG, vital signs, and laboratory results that are judged as not clinically significant by the Investigator during Screening.
排除标准
- •Significant renal, hepatic, bilirubin, cardiovascular, pulmonary, endocrine, metabolic, hematological, neurologic, or gastrointestinal (other than the one being studied) condition.
- •Subjects with diabetes mellitus are to be excluded.
- •Congenital or acquired long QT syndrome, or uncontrolled arrhythmias.
- •Prior surgery on the luminal GI tract.
- •History of any major psychiatric disorder, current depression or anxiety, alcohol abuse, or substance abuse in the last 2 years.
- •Any evidence or treatment for malignancy (with the exception of basal cell carcinoma) within the last 5 years.
- •Confirmed structural gastrointestinal disease.
- •Predominant symptoms of irritable bowel syndrome (IBS) (Rome II criteria) or gastroesophageal reflux disease (GERD) assessed at Visit 1 or
- •Female subjects who are pregnant, lactating, or are likely to become pregnant during the study.
- •Males and females of child-bearing potential must be abstinent or agree to use contraceptive regimens throughout the study.
- •Any history or condition which, in the opinion of the Investigator, makes the subject unsuitable for any of the procedures used during this study or would not allow for safe completion of the study.
- •Known hypersensitivity to gastroprokinetics or proton pump inhibitors.
- •Use of anti-ulcer medications, antacid/acid suppression medications, gastroprokinetics, aspirin (>325 mg daily), other NSAIDs, antibiotics, and other medications that effect the GI system within 2 weeks prior to Screening. Must be able to stay off these medications during the study, except for proton pump inhibitors (PPIs) administered during the PPI Run-in Period.
- •Required use of concomitant medications known to adversely interact with other gastroprokinetic agents or proton pump inhibitors.
- •H. pylori eradication therapy (PPIs, antibiotics, bismuth preparations) in the 2 weeks prior to the upper endoscopy.
- •Treatment for H. pylori required during the study.
- •Subject has received an investigational drug within 30 days or 10 half-lives, which ever is longer, or participated in more than 3 clinical studies within 12 months, prior to Visit
- •Previous treatment with YM
- •Employees of the Yamanouchi Group or CROs involved in the study.
- •More than one subject per household to participate in the study.
研究者
研究点 (59)
Loading locations...
相似试验
已完成
2 期
A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast CancerBreast CancerNCT01038804Astellas Pharma Inc101
已完成
3 期
A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT02324569Takeda240
已完成
2 期
Efficacy of SYR-472 in Subjects With Type 2 Diabetes MellitusDiabetes MellitusNCT00653185Takeda369
已完成
2 期
A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior TreatmentNon-Hodgkin's LymphomaNCT01007292Astellas Pharma Inc43
已完成
2 期
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary SyndromesAcute Coronary SyndromeNCT00994292Astellas Pharma Europe B.V.1,276