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Completed

NCT Number: NCT01280188

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

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.

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Key information

Conditions

Central Diabetes Insipidus Diabetes Insipidus Diabetes Insipidus, Neurogenic Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aichi Medical University, Nagakute, Aichi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be documented to have Central Diabetes Insipidus (CDI) by at least two of the following four criteria (a-d):
  • 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)
  • Complete and continuous control of the DI by desmopressin therapy without "breakthrough" diuresis, hypernatremia, hyponatremia, or symptoms or signs of water intoxication.
  • A deficient plasma vasopressin response to osmotic or non-osmotic stimulation.
  • 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

Treatment and study plan

Desmopressin Oral Melt

Drug

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

Desmopressin intranasal

Drug

Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1

Primary outcomes

  1. Change from Baseline in 24-hour Urine Volume

    Time frame: Day 0, Week 4

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 20, 2011
Registry last updated
Aug 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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