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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01280188
First received: January 19, 2011
Last updated: August 10, 2012
Last verified: August 2012

January 19, 2011
August 10, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01280188 on ClinicalTrials.gov Archive Site
  • 24-hour urine volume (mL) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
  • Hourly diuresis rate (mL/hr) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
  • Urine osmolality (mOsm/kg) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
  • Urine specific gravity (g/mL) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
  • Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
  • Serum sodium level [ Time Frame: up to Month 13 ] [ Designated as safety issue: Yes ]
  • Participants with Adverse Events Summarized by Incidence and Severity [ Time Frame: up to Month 13 ] [ Designated as safety issue: Yes ]
    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
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Interventions:
  • Drug: Desmopressin Oral Melt
  • Drug: Desmopressin intranasal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Both
6 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01280188
FE992026 CS43
No
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