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

NCT ID: NCT01280188

Last Updated: 2012-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Central Diabetes Insipidus

Keywords

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Desmopressin Oral Melt

Intervention Type: DRUG

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.

Desmopressin intranasal

Intervention Type: DRUG

Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1

Interventions

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.

Intervention Type: DRUG

Desmopressin intranasal

Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1

Intervention Type: DRUG

Other Intervention Names

Minirin; FE992026

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):

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 23811987 (View on PubMed)

Other Identifiers

FE992026 CS43

Identifier Type: -

Identifier Source: org_study_id