Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

Summary

The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.

Timeline

Start

2011-02

Primary completion

2012-01

Completion

2012-01

Outcome

Met primary endpoint

registry Desmopressin 75 μg Double-Blind vs Placebo Double-Blind; p <0.0001; Mean Difference (Final Values) -0.41 (95% CI -0.61 to -0.22) NCT01262456 ↗

registry Desmopressin 50 μg Double-Blind vs Placebo Double-Blind; p = 0.0003; Mean Difference (Final Values) -0.37 (95% CI -0.57 to -0.17) NCT01262456 ↗

registry Desmopressin 75 μg Double-Blind vs Placebo Double-Blind; p = 0.0004; Odds Ratio (OR) 2.04 (95% CI 1.38 to 3.03) NCT01262456 ↗

registry Desmopressin 50 μg Double-Blind vs Placebo Double-Blind; p = 0.0009; Odds Ratio (OR) 1.98 (95% CI 1.32 to 2.96) NCT01262456 ↗

Publications

• Results Weiss JP, Herschorn S, Albei CD, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):965-72. doi: 10.1016/j.juro.2012.12.112. Epub 2013 Feb 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desmopressin	Peptide	50 ug	Oral
Subject	Desmopressin	Peptide	75 ug	Oral
Subject	Desmopressin	Peptide	100 ug	Oral

Indications

No indication recorded.