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

• Sponsor: Ferring Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01280188
• Collaborator: (none)
• Enrollment: 20
• Locations: 5
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 4
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Central Diabetes Insipidus	Drug: Desmopressin Oral Melt; Drug: Desmopressin intranasal	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

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.

Drug: Desmopressin Oral Melt; 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: Minirin FE992026 ; Drug: Desmopressin intranasal; Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in 24-hour Urine Volume [Day 0, Week 4]

Secondary Outcome Measures

1. 24-hour urine volume (mL) [Day 0, Week 4]

2. Hourly diuresis rate (mL/hr) [Day 0, Week 4]

3. Urine osmolality (mOsm/kg) [Day 0, Week 4]

4. Urine specific gravity (g/mL) [Day 0, Week 4]

5. Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity [Day 0, Week 4]

6. Serum sodium level [up to Month 13]

7. Participants with Adverse Events Summarized by Incidence and Severity [up to Month 13]

   Includes abnormal lab values and vital signs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aichi Medical University	Nagakute, Aichi	Aichi	Japan
2	Nagoya University Hospital	Nagoya	Aichi	Japan
3	Toranomon Hospital	Minato	Tokyo	Japan
4	Osaka Saiseikai Nakatsu Hospital	Osaka		Japan
5	Saitama Medical Center Jichi Medical University	Saitama		Japan

Sponsors and Collaborators

• Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01280188
• Other Study ID Numbers: FE992026 CS43
• First Posted: Jan 20, 2011
• Last Update Posted: Aug 13, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Ferring Pharmaceuticals: Diabetes
• Additional relevant MeSH terms: Diabetes Insipidus; Diabetes Insipidus, Neurogenic; Deamino Arginine Vasopressin

Study Results

No Results Posted as of Aug 13, 2012