drugset / Trial / NCT01262456

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

NCT01262456

Phase 3 Completed 395 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Desmopressin Peptide 50 ug Oral
Subject Desmopressin Peptide 75 ug Oral
Subject Desmopressin Peptide 100 ug Oral

Indications

No indication recorded.