NCT01280188

A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).

Peroral Administration of Different Doses of Desmopressin Administered as a New Orally-Disintegrating Tablet and Desmopressin for Nasal Administration in the Treatment of CDI in Japanese Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI) patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of desmopressin.

Conditions

• Central Diabetes Insipidus

Interventions

Type	Name	Description
DRUG	Desmopressin Oral Melt	Oral melt formulation starts on Day 2. The target initial dose of the orally disintegrating tablet is 180µg/day (60µg taken 3 times a day) and adjusted to optimally stabilise the participant's condition.
DRUG	Desmopressin intranasal	Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2012-08-01
• First posted: 2011-01-20
• Last updated: 2012-08-13

Locations

5 sites across 1 country: Japan