ABT-229 FOR POSTPRANDIAL DIGESTIVE SYMPTOMS ASSOCIATED WITH FUNCTIONAL DYSPEPSIA

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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).