ABT 229 (2 YR TX ) FOR PP DIGESTIVE SYMPTOMS IN INSULIN REQUIRING DIA

ABT 229（2 年 TX）用于需要胰岛素的 DIA 中的 PP 消化症状

• 批准号: 6264437
• 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/6264437
• 关键词: clinical research; drug adverse effect; drug screening /evaluation; gastrointestinal agents; gastrointestinal disorder chemotherapy; gastrointestinal sign /symptom; human subject; human therapy evaluation; pharmacokinetics; quality of life; questionnaires

This is a Phase II, open-label, multi-center study of ABT-229 (Abbott Pharm.) administered at a fixed dose of 5 mg BID in diabetic patients with or without gastroparesis who have evidence of chronic postprandial digestive symptoms. Patients who were randomized to treatment in the M96-565 (SPID 0736) study are eligible to participate. Patients may receive study drug for up to two years. The objectives of this study are to assess the safety and efficacy of long term treatment (2 years) with 5 mg ABT-229 on postprandial digestive symptoms 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. The study will consist of follow up visits at one month and every 3 months after the start of treatment for up to 2 years. 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. Every 6 months, patients will be asked to complete the NDI Qualify of Life questionnaire and the 13C-Octanoic acid breath test (13C-OBT) procedures will be performed on the GCRC at the Month 1 Visit and at the Month 6,12,18, and 24 Visits. The GCRC dietary staff will prepare the standarized meal.

这是一项II期、开放标签、多中心研究，ABT-229（雅培制药）以固定剂量5mg BID给药于伴有或不伴有慢性餐后消化症状的胃轻瘫糖尿病患者。在M96-565 （SPID 0736）研究中被随机分配治疗的患者有资格参加。患者可以接受长达两年的研究药物。本研究的目的是评估5mg ABT-229长期治疗（2年）对胰岛素依赖型糖尿病患者餐后消化症状的安全性和有效性。在研究期间，患者将被要求避免使用其他促动力学和抗分泌药物。该研究将包括治疗开始后1个月和每3个月的随访，为期2年。每次就诊时，患者将接受实验室检查、妊娠试验（针对有生育潜力的女性）、药代动力学血浆样本、心电图和包括生命体征在内的体格检查。此外，患者将被要求：1)在所有就诊时完成症状问卷；2)每天记录日记以监测血糖控制和胰岛素剂量；3)报告自上次研究就诊以来的医生办公室、急诊室或医院就诊情况。每6个月，患者将被要求完成NDI生活质量调查问卷，并在第1个月以及第6、12、18和24个月对GCRC进行13c -辛酸呼吸测试（13C-OBT）程序。GCRC饮食工作人员将准备标准化膳食。