SUMMARYIntroduction: Motilin-receptor agonists are prokinetics; whether they relieve the symptoms of functional dyspepsia is unknown. We aimed to test the ef®cacy of the motilin agonist ABT-229 in functional dyspepsia patients with and without delayed gastric emptying. Methods: Patients were randomized with postprandial symptoms and documented functional dyspepsia by endoscopy (n 589 in intention-to-treat analysis). Patients were assigned to either the delayed or normal gastric emptying strata, based on a validated 13 C octanoic acid breath test. Patients were then further randomized within each strata, to receive one of four doses of ABT-229 (1.25, 2.5, 5 or 10 mg b.d. before breakfast and dinner) or placebo for 4 weeks, following a 2-week baseline. The primary outcome was the assessment of change in symptom severity over the 2 weeks from baseline to ®nal visit, based on a self-report questionnaire measuring severity on visual analogue scales.
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