ABT-229 FOR POSTPRANDIAL DIGESTIVE SYMPTOMS ASSOCIATED WITH FUNCTIONAL DYSPEPSIA

功能性消化不良或非溃疡性消化不良是一种上消化道疾病，其特征是持续或反复出现的上腹部不适症状，不能归因于结构或生化异常。目前还没有明确的潜在病理生理机制来解释这种疾病，也没有确凿的证据来确定一种明确有效的治疗方案。ABT-229是一种具有胃动素激动剂活性的新型大环内酯类药物，不具有任何显著的抗生素活性。本研究的目的是评估ABT-229与安慰剂相比治疗功能性消化不良相关餐后消化症状的疗效，并评估ABT-229在这些患者中的安全性。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。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)完成症状问卷；2)保持每日日记；3)报告自上次研究访问以来的医生办公室、急诊室或医院访问情况。受试者每次就诊时将对GCRC进行13c -辛酸呼吸测试。GCRC饮食工作人员将准备标准化膳食。6名患者已经完成了这项研究，并进入了长期疗效研究（SPID 8732）。

Functional dyspepsia or non-ulcer dyspepsia is an upper gastrointestinal disorder that is characterized by persistent or recurrent symptoms of upper abdominal discomfort which cannot be attributed to structural or biochemical abnormalities. Currently no definitive underlying pathophysiological mechanisms have been elucidated to explain this disorder and there is no conclusive evidence available identifying a definitive efficacious treatment regimen. ABT-229 is a novel macrolide with motilin agonist activity and devoid of any significant antibiotic activity. The objectives of this study are to assess the efficacy of ABT-229 compared to placebo for the treatment of postprandial digestive symptoms associated with functional dyspepsia and to assess the safety of ABT-229 in these patients. 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 2) keep a daily diary and 3) report physician office visits, ER visits, or hospital visits, since the previous study visit. Every visit the subject will have the 13C-Octanoic acid breath test performed on the GCRC. The GCRC dietary staff will prepare the standarized meal. Six patients have completed the study and have rolled into the long term efficacy study (SPID 8732).