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
  Purpose

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 Intervention Phase
Central Diabetes Insipidus
Drug: Desmopressin Oral Melt
Drug: Desmopressin intranasal
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change from Baseline in 24-hour Urine Volume [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Ferring Pharmaceuticals

Additional 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
Study First Received: January 19, 2011
Last Updated: August 10, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Ferring Pharmaceuticals:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Insipidus
Diabetes Insipidus, Neurogenic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 01, 2014