Previously, small studies have suggested that ondansetron has beneficial effects in diarrhea-predominant irritable bowel syndrome (IBS-D). This randomized, double-blind study evaluated the efficacy and safety of daily 12 mg RHB-102 an investigational bimodal release ondansetron tablet in IBS-D.
Overall stool consistency response rates were 56.0% and 35.3% and similar among male and female patients. Overall pain response and composite response rates favored RHB-102, although these differences were not statistically significant. Stool consistency response rates were enhanced in patients with baseline C-reactive protein above the median 59.5% vs 23.1%. Overall rates of adverse events were similar with a higher rate of constipation in RHB-102 patients that resolved rapidly on withholding treatment.