A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
Primary Purpose
Central Diabetes Insipidus
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Desmopressin Oral Melt
Desmopressin intranasal
Sponsored by
About this trial
This is an interventional treatment trial for Central Diabetes Insipidus focused on measuring Diabetes
Eligibility Criteria
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
Sites / Locations
- Aichi Medical University
- Nagoya University Hospital
- Toranomon Hospital
- Osaka Saiseikai Nakatsu Hospital
- Saitama Medical Center Jichi Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Desmopressin
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from Baseline in 24-hour Urine Volume
Secondary Outcome Measures
24-hour urine volume (mL)
Hourly diuresis rate (mL/hr)
Urine osmolality (mOsm/kg)
Urine specific gravity (g/mL)
Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity
Serum sodium level
Participants with Adverse Events Summarized by Incidence and Severity
Includes abnormal lab values and vital signs
Full Information
NCT ID
NCT01280188
First Posted
January 19, 2011
Last Updated
August 10, 2012
Sponsor
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01280188
Brief Title
A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Diabetes Insipidus
Keywords
Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desmopressin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Desmopressin Oral Melt
Other Intervention Name(s)
Minirin, FE992026
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Desmopressin intranasal
Intervention Description
Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
Primary Outcome Measure Information:
Title
Change from Baseline in 24-hour Urine Volume
Time Frame
Day 0, Week 4
Secondary Outcome Measure Information:
Title
24-hour urine volume (mL)
Time Frame
Day 0, Week 4
Title
Hourly diuresis rate (mL/hr)
Time Frame
Day 0, Week 4
Title
Urine osmolality (mOsm/kg)
Time Frame
Day 0, Week 4
Title
Urine specific gravity (g/mL)
Time Frame
Day 0, Week 4
Title
Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity
Time Frame
Day 0, Week 4
Title
Serum sodium level
Time Frame
up to Month 13
Title
Participants with Adverse Events Summarized by Incidence and Severity
Description
Includes abnormal lab values and vital signs
Time Frame
up to Month 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Medical University
City
Nagakute, Aichi
State/Province
Aichi
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Toranomon Hospital
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Osaka Saiseikai Nakatsu Hospital
City
Osaka
Country
Japan
Facility Name
Saitama Medical Center Jichi Medical University
City
Saitama
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23811987
Citation
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.
Results Reference
derived
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A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
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