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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
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 19, 2011
First Posted Date  ICMJE January 20, 2011
Last Update Posted Date August 13, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
Change from Baseline in 24-hour Urine Volume [ Time Frame: Day 0, Week 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Central Diabetes Insipidus
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01280188
Other Study ID Numbers  ICMJE FE992026 CS43
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date August 2012

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