Clinical Trial: A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
Sponsor: Ferring Pharmaceuticals
Current Primary Outcome: Change from Baseline in 24-hour Urine Volume [ Time Frame: Day 0, Week 4 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 24-hour urine volume (mL) [ Time Frame: Day 0, Week 4 ]
- Hourly diuresis rate (mL/hr) [ Time Frame: Day 0, Week 4 ]
- Urine osmolality (mOsm/kg) [ Time Frame: Day 0, Week 4 ]
- Urine specific gravity (g/mL) [ Time Frame: Day 0, Week 4 ]
- Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity [ Time Frame: Day 0, Week 4 ]
- Serum sodium level [ Time Frame: up to Month 13 ]
- Participants with Adverse Events Summarized by Incidence and Severity [ Time Frame: up to Month 13 ]Includes abnormal lab values and vital signs
Original Secondary Outcome: Same as current
Information By: Ferring Pharmaceuticals
Dates:
Date Received: January 19, 2011
Date Started: January 2011
Date Completion:
Last Updated: August 10, 2012
Last Verified: August 2012
