A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
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ClinicalTrials.gov Identifier: NCT01280188 |
Recruitment Status :
Completed
First Posted : January 20, 2011
Last Update Posted : August 13, 2012
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Condition or disease | Intervention/treatment | Phase |
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Central Diabetes Insipidus | Drug: Desmopressin Oral Melt Drug: Desmopressin intranasal | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
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Experimental: Desmopressin
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.
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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.
Other Names:
Drug: Desmopressin intranasal Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1 |
- 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 [ Time Frame: up to Month 13 ]Includes abnormal lab values and vital signs

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Ages Eligible for Study: | 6 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Participants must be documented to have Central Diabetes Insipidus (CDI) by at least two of the following four criteria (a-d):
- Failure to increase urine osmolality above 300 mOsm/kg during a period of fluid deprivation sufficient to raise plasma osmolality and sodium above the upper limit of normal level for the reference laboratory (usually 295 mOsm/kg and 148 mEq/l, respectively)
- Complete and continuous control of the DI by desmopressin therapy without "breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of water intoxication.
- A deficient plasma vasopressin response to osmotic or non-osmotic stimulation.
- Absence of the posterior pituitary bright spot on T-1 weighted midsagittal magnetic resonance imaging (MRI) of the brain.
- 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:
- Presence or a history of nephrogenic diabetes insipidus or diabetes mellitus
- Presence of uncorrected hypothyroidism, hypoadrenalism or hypogonadism
- Abnormalities or disease of the oral cavity that might affect the release and absorption of drug
- Unable to be placed on water-intake restriction starting from two hours before bedtime
- Presence of a hypothalamus abnormality leading to thirst disorder
- Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
- Uncontrolled hypertension
- Treatment with another investigational product within the past 3 months
- Concurrent treatment with diuretics, chlorpropamide, tricyclic antidepressants, indomethacin, carbamazepine
- Alcohol dependency or drug abuse
- Breastfeeding, pregnant, or likely to become pregnant
- A mental condition, the lack of decision-making ability, dementia or a speech handicap
- Any other reason that the Investigator believes inappropriate

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280188
Japan | |
Aichi Medical University | |
Nagakute, Aichi, Aichi, Japan | |
Nagoya University Hospital | |
Nagoya, Aichi, Japan | |
Toranomon Hospital | |
Minato, Tokyo, Japan | |
Osaka Saiseikai Nakatsu Hospital | |
Osaka, Japan | |
Saitama Medical Center Jichi Medical University | |
Saitama, Japan |
Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
Responsible Party: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01280188 |
Other Study ID Numbers: |
FE992026 CS43 |
First Posted: | January 20, 2011 Key Record Dates |
Last Update Posted: | August 13, 2012 |
Last Verified: | August 2012 |
Diabetes |
Diabetes Insipidus Diabetes Insipidus, Neurogenic Endocrine System Diseases Kidney Diseases Urologic Diseases Pituitary Diseases |
Deamino Arginine Vasopressin Hemostatics Coagulants Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |