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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desmopressin | Experimental | Day 1 - participants continue desmopressin intranasal. Day 2 up to Day 4 - Desmopressin oral melt to optimum dose. Continue optimum dose for the four week treatment and one year follow-up periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desmopressin Oral Melt | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in 24-hour Urine Volume | Day 0, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urine volume (mL) | Day 0, Week 4 | |
| Hourly diuresis rate (mL/hr) | Day 0, Week 4 | |
| Urine osmolality (mOsm/kg) |
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Inclusion Criteria:
Participants must be documented to have Central Diabetes Insipidus (CDI) by at least two of the following four criteria (a-d):
Given written informed consent prior to any trial-related procedure is performed
24 hour urine volume (mL), urine osmolality (mOsm/kg), urine specific gravity, and serum sodium (mEq/L) maintained at a normal level by desmopressin nasal administration
Outpatient
The participant is, in the investigator's opinion, otherwise healthy
Be willing and able to comply with the protocol requirements including restriction of water intake
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University | Nagakute, Aichi | Aichi-ken | Japan | |||
| Nagoya University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23811987 | Derived | Arima H, Oiso Y, Juul KV, Norgaard JP. Efficacy and safety of desmopressin orally disintegrating tablet in patients with central diabetes insipidus: results of a multicenter open-label dose-titration study. Endocr J. 2013;60(9):1085-94. doi: 10.1507/endocrj.ej13-0165. Epub 2013 Jun 28. |
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| ID | Term |
|---|---|
| D020790 | Diabetes Insipidus, Neurogenic |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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|
| Desmopressin intranasal | Drug | Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1 |
|
| Day 0, Week 4 |
| Urine specific gravity (g/mL) | Day 0, Week 4 |
| Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity | Day 0, Week 4 |
| Serum sodium level | up to Month 13 |
| Participants with Adverse Events Summarized by Incidence and Severity | Includes abnormal lab values and vital signs | up to Month 13 |
| Nagoya |
| Aichi-ken |
| Japan |
| Osaka Saiseikai Nakatsu Hospital | Osaka | Osaka | Japan |
| Saitama Medical Center Jichi Medical University | Saitama | Saitama | Japan |
| Toranomon Hospital | Minato | Tokyo | Japan |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |