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

Central Diabetes Insipidus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280188
• Other study ID #: FE992026 CS43
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2011
• Last updated: August 10, 2012
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Diabetes Insipidus
• Diabetes Insipidus

Intervention

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.
• Desmopressin intranasal
Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1

Locations

Country	Name	City	State
Japan	Toranomon Hospital	Minato	Tokyo
Japan	Aichi Medical University	Nagakute, Aichi	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Osaka Saiseikai Nakatsu Hospital	Osaka
Japan	Saitama Medical Center Jichi Medical University	Saitama

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in 24-hour Urine Volume		Day 0, Week 4	No
Secondary	24-hour urine volume (mL)		Day 0, Week 4	No
Secondary	Hourly diuresis rate (mL/hr)		Day 0, Week 4	No
Secondary	Urine osmolality (mOsm/kg)		Day 0, Week 4	No
Secondary	Urine specific gravity (g/mL)		Day 0, Week 4	No
Secondary	Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity		Day 0, Week 4	No
Secondary	Serum sodium level		up to Month 13	Yes
Secondary	Participants with Adverse Events Summarized by Incidence and Severity	Includes abnormal lab values and vital signs	up to Month 13	Yes