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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
Aichi Medical University
Nagakute, Aichi, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, Japan
Saitama Medical Center Jichi Medical University
Saitama, Saitama, Japan
Change from Baseline in 24-hour Urine Volume
Time frame: Day 0, Week 4
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
Includes abnormal lab values and vital signs
Time frame: up to Month 13
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Toranomon Hospital
Minato, Tokyo, Japan