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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280188
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : August 13, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

January 19, 2011
January 20, 2011
August 13, 2012
January 2011
August 2011   (Final data collection date for primary outcome measure)
Change from Baseline in 24-hour Urine Volume [ Time Frame: Day 0, Week 4 ]
Same as current
Complete list of historical versions of study NCT01280188 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
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
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.
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Central Diabetes Insipidus
  • 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:
    • Minirin
    • FE992026
  • Drug: Desmopressin intranasal
    Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
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.
  • Drug: Desmopressin Oral Melt
  • Drug: Desmopressin intranasal
Arima H, Oiso Y, Juul KV, Nørgaard 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. Epub 2013 Jun 28.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2012
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 75 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
FE992026 CS43
Not Provided
Not Provided
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP