Clinical Trials Resource Center

Gastroenteritis

June 26, 2017

RedHill Biopharma reported results of a phase III study of Bekinda (RHB-102) 24mg for acute gastroenteritis and gastritis. The randomized, double-blind, placebo-controlled GUARD study enrolled 321 adults and children over the age of 12 at 21 clinical sites in the U.S. and randomized in a 60:40 ratio to receive either Bekinda 24mg or placebo, respectively. The primary endpoint of the study was the proportion of patients without further vomiting, without rescue medication and who were not given intravenous hydration from 30 minutes post first dose of the study drug until 24 hours post dose, compared to placebo. Top-line results indicated that the phase III GUARD study successfully met its primary endpoint in the Intent to Treat (ITT) population (p=0.04), despite high positive outcome rate in the placebo arm. Bekinda improved the efficacy outcome by 21%; 65.6% of Bekinda-treated patients as compared to 54.3% of placebo patients (p=0.04; n=192 in the Bekinda group and n=129 in the placebo group). Correcting for a randomization error, the difference in effect is greater with 65.8% vs. 53.9% favoring Bekinda vs. placebo in reaching the primary endpoint of the study (p=0.03). In per-protocol (PP) analysis of patients who met all protocol entry criteria and for which the diagnosis of gastroenteritis was confirmed (n=177 in the Bekinda group and n=122 in the placebo group), Bekinda improved the efficacy outcome by 27%; 69.5% of patients in the Bekinda group vs. 54.9% in the placebo group (p=0.01). The study successfully met its primary endpoint of efficacy in treatment of acute gastroenteritis. Bekinda was found to be safe and well-tolerated in this indication. 

February 20, 2012

Soligenix issued preliminary results from a phase I/II trial of SGX201, a time-release formulation of oral beclomethasone dipropionate, for the prevention of acute radiation enteritis. This multicenter, open-label, sequential, dose-escalation study, dubbed BDP-ENT-01, enrolled 16 subjects with rectal cancer who were scheduled to undergo concurrent radiation and chemotherapy prior to surgery. The subjects received 1, 2, 3 or 4mg of SGX201 three times daily, with dosing administered throughout the duration of radiation therapy plus one week. Oral administration of SGX201 was safe and well tolerated across all four dose groups. There was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis. The incidence of diarrhea was lower than that seen in historical control data.

March 2, 2009

Optimer reported positive results from a phase III trial of Prulifloxacin for the treatment of bacterial gastroenteritis (travelers diarrhea). This randomized, double-blind, placebo-controlled study, dubbed OPT-099-002, enrolled 373 adult subjects who were traveling through India, Guatemala or Mexico and diagnosed with bacterial gastroenteritis. The subjects received either 600mg of oral Prulifloxacin or placebo, once daily over three days. The primary efficacy endpoint was Time to the Last Unformed Stool, defined as the time in hours from the first dose of study medication to the passage of the last unformed stool (TLUS). Prulifloxacin was statistically superior to placebo in TLUS in both the modified intent-to-treat population (n≡200) and microbiologically evaluable population (n≡173). The median TLUS for the Prulifloxacin treatment arm was 32.8 hours; (p-value of <0.0001 versus placebo). Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo.

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