ABT-229 FOR POSTPRANDIAL DIGESTIVE SYMPTOMS/FUNCTIONAL DYSPEPSIA M96-586

本研究的目的是评估ABT-229长期治疗（2年）对功能性消化不良患者餐后消化道症状的安全性和有效性。要求患者在研究期间避免使用其他促动力剂和抗分泌剂。 本研究将包括治疗开始后1个月和每3个月的随访访视，持续2年。 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）在所有访视时填写症状问卷，2）记录每日日记，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。 每6个月，将要求患者完成NDI生活质量问卷，并在第1个月访视和第6、12、18和24个月访视时对GCRC进行13 C-辛酸呼气试验（13 C-OBT）程序。 GCRC膳食工作人员将准备标准化膳食。 迄今为止，已入组6例患者，但均未完成本研究。

The objectives of this study are to assess the safety and efficacy of long-term treatment (2 years) with ABT-229 on postprandial digestive symptoms in patients with functional dyspepsia. 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 and 3) report physician office visits, ER visits, or hospital visits, since the previous study visit. Every 6 months, 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 at the Month 1 Visit and at the Month 6,12,18, and 24 Visits. The GCRC dietary staff will prepare the standarized meal. Six patients have been enrolled to date but none have completed this study.