- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280188
A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
August 10, 2012 updated by: Ferring Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan
- Osaka Saiseikai Nakatsu Hospital
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Saitama, Japan
- Saitama Medical Center Jichi Medical University
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Aichi
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Nagakute, Aichi, Aichi, Japan
- Aichi Medical University
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Nagoya, Aichi, Japan
- Nagoya University Hospital
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Tokyo
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Minato, Tokyo, Japan
- Toranomon Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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:
Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in 24-hour Urine Volume
Time Frame: Day 0, Week 4
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Day 0, Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-hour urine volume (mL)
Time Frame: Day 0, Week 4
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Day 0, Week 4
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Hourly diuresis rate (mL/hr)
Time Frame: Day 0, Week 4
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Day 0, Week 4
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Urine osmolality (mOsm/kg)
Time Frame: Day 0, Week 4
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Day 0, Week 4
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Urine specific gravity (g/mL)
Time Frame: Day 0, Week 4
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Day 0, Week 4
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Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity
Time Frame: Day 0, Week 4
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Day 0, Week 4
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Serum sodium level
Time Frame: up to Month 13
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up to Month 13
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Participants with Adverse Events Summarized by Incidence and Severity
Time Frame: up to Month 13
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Includes abnormal lab values and vital signs
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up to Month 13
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
January 19, 2011
First Submitted That Met QC Criteria
January 19, 2011
First Posted (Estimate)
January 20, 2011
Study Record Updates
Last Update Posted (Estimate)
August 13, 2012
Last Update Submitted That Met QC Criteria
August 10, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE992026 CS43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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