NCT00050882已完成2 期
A 12-Week Study Conducted at Multiple Centers, Blinded to Both the Patient and Doctor, Evaluating for Safety and Effectiveness Two Dosages of an Investigational Agent (GM-611) Versus a Placebo, That Are Randomly Assigned to Patients With Diabetic Gastroparesis
Chugai Pharma USA129 个研究点 分布在 1 个国家开始时间: 2002年12月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 129
研究概览
简要总结
This study is intended to evaluate the potential to relieve the symptoms associated with gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg, 10mg or placebo to type I or II diabetics who require insulin.
Additionally the study will evaluate the safety and tolerability of GM-611 compared to placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic control.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Inclusion Criteria - Others Stipulated within the Protocol
- •The study physician must assure you have/are:
- •Must be at least 18 years of age and have diabetes mellitus requiring insulin, which may be in addition to oral anti-diabetic agents.
- •At least a three month history of the symptoms of gastroparesis that may include: early satiety (feeling full soon after beginning a meal), persistent fullness (long after eating), abdominal distention or bloating, nausea and vomiting. - No evidence of mechanical gastric obstruction, or other gastric problems since the onset of gastroparesis symptoms.
- •You may be required to under go a Gastric Emptying Test (GET) procedure.
- •You must be willing and able to maintain a daily telephone diary and consent to participate in this study.
排除标准
- •Major Exclusion Criteria - Others Stipulated within the Protocol
- •The study physician must assure you do not have/are not:
- •Prior history of gastric surgery, excluding reflux surgery.
- •Inability to withdraw from current prokinetic agents (e.g., metoclopramide, erythromycin, others) prior to, and during the study.
- •Unstable current medical or surgical condition, or a recent history of frequent hospitalizations.
- •A history of: HIV, recurring infection affecting the gastrointestinal track, cirrhosis, acute or chronic liver disease, active pancreatitis, cholecystitis, psychosis, severe depression, Parkinson's disease, myopathy, scleroderma, eating disorder, or organ transplant.
- •Evidence or history of QT-prolongation, or use of drugs that are, or may be associated with QT-prolongation are prohibited.
- •May not be pregnant, breast-feeding or not using approved methods of contraception.
- •An allergy or intolerance to macrolide antibiotics (e.g., erythromycin).
- •Use of any investigational drug within 30 days prior to screening.
研究者
研究点 (129)
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