ORAL DOSES OF ABT-229 FOR POSTPRANDIAL DIGESTIVE SYMPTOMS/INSULI RQRNG DIABETES

口服 ABT-229 治疗餐后消化症状/INSULI RQRNG 糖尿病

• 批准号: 6115341
• 负责人: JAMES M GORDON
• 金额: $ 1.92万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115341
• 关键词: clinical research; dosage; drug screening /evaluation; gastrointestinal disorder chemotherapy; gastrointestinal hormones; gastrointestinal sign /symptom; human subject; human therapy evaluation; insulin dependent diabetes mellitus; macrolide antibiotics; oral administration; paralysis; pharmacokinetics; placebos; stomach

ABT-229 is a new drug that belongs to the class of macrolides with motilin agonist activity and without significant antibotic activity. Treatment of diabetic gastroparesis with motility agents have met with some success. ABT-229 has the potential to alter the pathophysiology and improve the symptoms in patients with diabetic gastroparesis without altering the normal gut flora. The objectives of this study are to assess the efficacy of four different doses of ABT-229 compared to placebo for the treatment of postprandial digestive symptoms and to assess the safety of ABT-229 in patients with insulin-requiring diabetes. Patients will be required to refrain from the use of other prokinetic and anti-secretory agents during the study. At each visit, patients will have laboratory tests, pregnancy tests (for females of child bearing potential), pharmacokinetic plasma samples, electrocardiograms, and physical examinations including vital signs. In addition patients will be asked to 1) complete a symptom questionnaire at all visits 2) keep a daily diary to monitor glycemia control and insulin dosing and 3) report physician office visits, ER visits, or hospital visits, since the previous study visit. Patients will be asked to compelte the NDI Qualify of Life questionnaire and the 13C-Octanoic acid breath test (13C-OBT) procedures will be performed on the GCRC. The GCRC dietary staff will prepare the standarized meal.

ABT-229是一种具有胃动素激动活性的大环内酯类新药，无明显的抗菌活性。 用动力剂治疗糖尿病胃轻瘫已取得一些成功。ABT-229有可能改变糖尿病胃轻瘫患者的病理生理学并改善症状，而不改变正常的肠道植物群。 本研究的目的是评估四种不同剂量的ABT-229与安慰剂相比治疗餐后消化道症状的疗效，并评估ABT-229在需要胰岛素的糖尿病患者中的安全性。要求患者在研究期间避免使用其他促动力剂和抗分泌剂。 每次访视时，患者将接受实验室检查、妊娠试验（对于有生育能力的女性）、药代动力学血浆样本、心电图和体格检查（包括生命体征）。 此外，将要求患者1）在所有访视时完成症状问卷，2）记录每日日记以监测血糖控制和胰岛素给药，3）报告自上次研究访视以来的医生办公室访视、ER访视或医院访视。将要求患者填写NDI生活质量问卷，并对GCRC进行13 C-辛酸呼气试验（13 C-OBT）。 GCRC膳食工作人员将准备标准化膳食。