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

Phase 3

Completed

• Conditions: Central Diabetes Insipidus
• Interventions: Drug: Desmopressin Oral Melt; Drug: Desmopressin intranasal

• Registration Number: NCT01280188
• Lead Sponsor: Ferring Pharmaceuticals

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 available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Primary Completion: 2011-08
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-10
• Last Update Posted: 2012-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Desmopressin	Desmopressin Oral Melt	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.
Desmopressin	Desmopressin intranasal	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in 24-hour Urine Volume	Day 0, Week 4

Secondary Outcome Measures

Name	Time	Method
Serum sodium level	up to Month 13
Urine osmolality (mOsm/kg)	Day 0, Week 4
Urine specific gravity (g/mL)	Day 0, Week 4
Hourly diuresis rate (mL/hr)	Day 0, Week 4
Participants with Adverse Events Summarized by Incidence and Severity	up to Month 13	Includes abnormal lab values and vital signs
24-hour urine volume (mL)	Day 0, Week 4
Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity	Day 0, Week 4

Trial Locations

Locations (5)

Aichi Medical University; 🇯🇵 Nagakute, Aichi, Aichi, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Saitama Medical Center Jichi Medical University; 🇯🇵 Saitama, Japan

Osaka Saiseikai Nakatsu Hospital; 🇯🇵 Osaka, Japan

Toranomon Hospital; 🇯🇵 Minato, Tokyo, Japan