Ventrus BioSciences (VTUS) Announces Completion of Enrollment with Phase 3 Trial of Diltiazem
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Ventrus BioSciences, Inc. (Nasdaq: VTUS) announced that S.L.A. Pharma has completed patient enrollment and randomization in the first Phase 3 clinical trial of Diltiazem (VEN 307) in patients with anal fissures. Initial top-line data from the Phase 3 study is expected to be available in May 2012. Ventrus Biosciences has licensed the North American rights to diltiazem hydrochloride cream from S.L.A. Pharma.
The Phase 3 diltiazem study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of diltiazem hydrochloride cream in subjects with anal fissure and is being conducted in 31 centers in Europe. The primary endpoint using an 11-point numerical pain rating scale (Likert-like scale) evaluates the change from baseline in the average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Consistent with the protocol for this trial, 465 patients have been randomized to diltiazem hydrochloride 2%, 4% cream, or placebo for 8 weeks of treatment, to be followed by a 4 week blinded observation period.
The Phase 3 diltiazem study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of diltiazem hydrochloride cream in subjects with anal fissure and is being conducted in 31 centers in Europe. The primary endpoint using an 11-point numerical pain rating scale (Likert-like scale) evaluates the change from baseline in the average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Consistent with the protocol for this trial, 465 patients have been randomized to diltiazem hydrochloride 2%, 4% cream, or placebo for 8 weeks of treatment, to be followed by a 4 week blinded observation period.
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