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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01280188
• Date of registration: 19/01/2011
• Prospective Registration: No
• Primary sponsor: Ferring Pharmaceuticals
• Public title: A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
• Scientific 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
• Date of first enrolment: January 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01280188
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants must be documented to have Central Diabetes Insipidus (CDI) by at least
two of the following four criteria (a-d):

1. 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)

2. Complete and continuous control of the DI by desmopressin therapy without
"breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of
water intoxication.

3. A deficient plasma vasopressin response to osmotic or non-osmotic stimulation.

4. 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



Age minimum: 6 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Central Diabetes Insipidus

Intervention(s)

Drug: Desmopressin intranasal

Drug: Desmopressin Oral Melt

Primary Outcome(s)

Change from Baseline in 24-hour Urine Volume [Time Frame: Day 0, Week 4]

Secondary Outcome(s)

Participants with Adverse Events Summarized by Incidence and Severity [Time Frame: up to Month 13]

Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity [Time Frame: Day 0, Week 4]

Hourly diuresis rate (mL/hr) [Time Frame: Day 0, Week 4]

Serum sodium level [Time Frame: up to Month 13]

Urine osmolality (mOsm/kg) [Time Frame: Day 0, Week 4]

24-hour urine volume (mL) [Time Frame: Day 0, Week 4]

Urine specific gravity (g/mL) [Time Frame: Day 0, Week 4]

Secondary ID(s)

FE992026 CS43

Source(s) of Monetary Support

Please refer to primary and secondary sponsors