A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
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
1 other identifier
interventional
20
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 13, 2012
August 1, 2012
7 months
January 19, 2011
August 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in 24-hour Urine Volume
Day 0, Week 4
Secondary Outcomes (7)
24-hour urine volume (mL)
Day 0, Week 4
Hourly diuresis rate (mL/hr)
Day 0, Week 4
Urine osmolality (mOsm/kg)
Day 0, Week 4
Urine specific gravity (g/mL)
Day 0, Week 4
Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity
Day 0, Week 4
- +2 more secondary outcomes
Study Arms (1)
Desmopressin
EXPERIMENTALDay 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
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.
Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Aichi Medical University
Nagakute, Aichi, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, Japan
Saitama Medical Center Jichi Medical University
Saitama, Saitama, Japan
Toranomon Hospital
Minato, Tokyo, Japan
Related Publications (1)
Arima H, Oiso Y, Juul KV, Norgaard 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. doi: 10.1507/endocrj.ej13-0165. Epub 2013 Jun 28.
PMID: 23811987DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2011
First Posted
January 20, 2011
Study Start
January 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2012
Last Updated
August 13, 2012
Record last verified: 2012-08