A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Central Diabetes Insipidus
Intervention: Desmopressin Oral Melt (Drug); Desmopressin intranasal (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
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.
Clinical Details
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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from Baseline in 24-hour Urine Volume
Secondary outcome: 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
Eligibility
Minimum age: 6 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Osaka Saiseikai Nakatsu Hospital, Osaka, Japan
Saitama Medical Center Jichi Medical University, Saitama, Japan
Aichi Medical University, Nagakute, Aichi, Aichi, Japan
Nagoya University Hospital, Nagoya, Aichi, Japan
Toranomon Hospital, Minato, Tokyo, Japan
Additional Information
Starting date: January 2011
Last updated: August 10, 2012
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