ABT-229 FOR POSTPRANDIAL DIGESTIVE SYMPTOMS ASSOCIATED WITH FUNCTIONAL DYSPEPSIA

ABT-229 用于治疗与功能性消化不良相关的餐后消化症状

• 批准号: 6115338
• 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/6115338
• 关键词: clinical research; drug screening /evaluation; gastrointestinal disorder chemotherapy; gastrointestinal sign /symptom; human subject; human therapy evaluation; macrolide antibiotics; placebos

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).

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，其特征在于上腹部不适的持续或复发症状，其不能归因于结构或生化异常。 目前尚未阐明明确的潜在病理生理学机制来解释这种疾病，也没有确定有效治疗方案的确凿证据。 ABT-229是一种新的大环内酯类药物，具有胃动素激动剂活性，没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的餐后消化症状的疗效，并评估ABT-229在这些患者中的安全性。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）完成症状问卷，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。 每次访视时，受试者将在GCRC上进行13 C-辛酸呼气试验。 GCRC膳食工作人员将准备标准化膳食。 6例患者已完成研究并进入长期疗效研究（SPID 8732）。