A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01280188
First received: January 19, 2011
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Central Diabetes Insipidus |
Drug: Desmopressin Oral Melt Drug: Desmopressin intranasal |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Change from Baseline in 24-hour Urine Volume [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 24-hour urine volume (mL) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
- Hourly diuresis rate (mL/hr) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
- Urine osmolality (mOsm/kg) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
- Urine specific gravity (g/mL) [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
- Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity [ Time Frame: Day 0, Week 4 ] [ Designated as safety issue: No ]
- Serum sodium level [ Time Frame: up to Month 13 ] [ Designated as safety issue: Yes ]
- Participants with Adverse Events Summarized by Incidence and Severity [ Time Frame: up to Month 13 ] [ Designated as safety issue: Yes ]Includes abnormal lab values and vital signs
| Enrollment: | 20 |
| Study Start Date: | January 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Drug: Desmopressin intranasal
Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
|
Eligibility| Ages Eligible for Study: | 6 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280188
Locations
| Japan | |
| Aichi Medical University | |
| Nagakute, Aichi, Aichi, Japan | |
| Nagoya University Hospital | |
| Nagoya, Aichi, Japan | |
| Toranomon Hospital | |
| Minato, Tokyo, Japan | |
| Osaka Saiseikai Nakatsu Hospital | |
| Osaka, Japan | |
| Saitama Medical Center Jichi Medical University | |
| Saitama, Japan | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01280188 History of Changes |
| Other Study ID Numbers: | FE992026 CS43 |
| Study First Received: | January 19, 2011 |
| Last Updated: | August 10, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Ferring Pharmaceuticals:
|
Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Insipidus Diabetes Insipidus, Neurogenic Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Kidney Diseases Urologic Diseases Pituitary Diseases Deamino Arginine Vasopressin |
Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013