Investigational drug improves stool consistency in IBS-D
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An investigational, bimodal release ondansetron tablet improved stool consistency in patients with diarrhea-predominant irritable bowel syndrome, according to study results.
“Immediate release ondansetron has been evaluated in several small studies at doses from 4 mg daily to 16 mg daily, with favorable results, and no evidence of ischemic colitis or other significant side effects have been observed,” Terry F. Plasse, MD, of RedHill Biopharma and colleagues wrote. “RHB-102 is an investigational bimodal release formulation of ondansetron.”
Researchers recruited 127 patients with IBS-D based on Rome III criteria and had a Bristol Stool Scale of at least 6 on 2 or more days weekly and an average daily worst pain intensity of at least 3. They randomly assigned patients to receive either RHB-102 or placebo once daily for 8 weeks.
The primary outcome of the study was overall stool consistency response for at least 4 of 8 weeks. Investigators also assessed the drug’s efficacy in overall abdominal pain, overall composite response and safety endpoints.
Stool consistency response rates were 56% in the RHB-102 group and 35.2% in the placebo group (P =.036), with similar response rates among men and women.
Patients who received the drug had higher pain response and composite response rate, but the differences were not significant. Stool consistency response rates were higher in patients with higher baseline C-reactive protein (P = .009).
In the safety analysis, researchers found that overall rates of adverse events were similar. Patients who received RHB-102 had higher rates of constipation (13.3% vs. 3.9%), which resolved after withholding treatment.
“An intriguing relationship between baseline CRP level, even when normal, and response to treatment was noted, suggesting that level of inflammation may affect outcome of therapy,” Plasse and colleagues wrote. “This remains to be confirmed in future studies.”
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