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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Central Diabetes Insipidus Drug: Desmopressin Oral Melt Drug: Desmopressin intranasal Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2012

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Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in 24-hour Urine Volume [ Time Frame: Day 0, Week 4 ]

Secondary Outcome Measures :
  1. 24-hour urine volume (mL) [ Time Frame: Day 0, Week 4 ]
  2. Hourly diuresis rate (mL/hr) [ Time Frame: Day 0, Week 4 ]
  3. Urine osmolality (mOsm/kg) [ Time Frame: Day 0, Week 4 ]
  4. Urine specific gravity (g/mL) [ Time Frame: Day 0, Week 4 ]
  5. Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity [ Time Frame: Day 0, Week 4 ]
  6. Serum sodium level [ Time Frame: up to Month 13 ]
  7. Participants with Adverse Events Summarized by Incidence and Severity [ Time Frame: up to Month 13 ]
    Includes abnormal lab values and vital signs


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280188


Locations
Japan
Aichi Medical University
Nagakute, Aichi, Aichi, Japan
Nagoya University Hospital
Nagoya, Aichi, Japan
Toranomon Hospital
Minato, Tokyo, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Japan
Saitama Medical Center Jichi Medical University
Saitama, Japan
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01280188     History of Changes
Other Study ID Numbers: FE992026 CS43
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: August 13, 2012
Last Verified: August 2012

Keywords provided by Ferring Pharmaceuticals:
Diabetes

Additional relevant MeSH terms:
Diabetes Insipidus
Diabetes Insipidus, Neurogenic
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
 Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs