drugset / Trial / NCT01184859

Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo

NCT01184859

Phase 2 Completed 116 enrolled Ferring Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.

Timeline

Start
2010-07
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Desmopressin Peptide 10 ug Subcutaneous
Subject Desmopressin Peptide 25 ug Subcutaneous
Subject Desmopressin Peptide 50 ug Subcutaneous
Subject Desmopressin Peptide 100 ug Subcutaneous

Indications