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The combination of 'placebo + PPI' refers to a control arm used in clinical trials, most notably in a Phase 2b study (NCT01472939) sponsored by Shire (now Takeda) evaluating the 5-HT4 receptor agonist revexepride. In this context, patients with gastroesophageal reflux disease (GERD) who were partially responsive to proton pump inhibitor (PPI) therapy received an inactive placebo alongside their standard-of-care PPI regimen. PPIs are a class of small molecule drugs that reduce gastric acid production by irreversibly inhibiting the H+/K+-ATPase enzyme in gastric parietal cells. The trial demonstrated that the addition of revexepride was not superior to the 'placebo + PPI' control in managing persistent regurgitation, leading to the discontinuation of revexepride's clinical development for this indication.
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