BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis

Summary

Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis. The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.

Timeline

Start

2014-12-08

Primary completion

2017-02-13

Completion

2017-02-16

Outcome

Met primary endpoint

registry analysis (superiority test); RHB-102 vs Placebo Oral Tablet; p = 0.0406; Odds Ratio (OR) 1.6081 (95% CI 1.0194 to 2.5368) NCT02246439 ↗

paper Treatment successes were observed in 126 patients in the bimodal release ondansetron group (65.6%) compared with 70 patients in the placebo group (54.3%), PMID 31702802 ↗

release “The Phase III GUARD study successfully met its primary endpoint of efficacy in the treatment of acute gastroenteritis and gastritis” redhillbio.com ↗

release “Phase III GUARD study with BEKINDA® 24 mg successfully met its primary endpoint” redhillbio.com ↗

release “The Phase 3 GUARD study with RHB-102 (24mg) in acute gastroenteritis and gastritis successfully met its primary endpoint” redhillbio.com ↗

Publications

• Silverman RA, House SL, Meltzer AC, Hahn B, Lovato LM, Avarello J, Miller JB, Kalfus IN, Fathi R, Raday G, Plasse TF, Yan EC. Bimodal Release Ondansetron for Acute Gastroenteritis Among Adolescents and Adults: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914988. doi: 10.1001/jamanetworkopen.2019.14988.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ondansetron	Other / unclassified	24 mg	Oral

Indications