Central Diabetes InsipidusPhase 3NCT01280188
A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
A Phase 3 study testing Desmopressin Oral Melt and Desmopressin intranasal in people with Central Diabetes Insipidus, run by Ferring Pharmaceuticals at 5 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Central Diabetes Insipidus
- What is being tested?
- Desmopressin Oral Melt and Desmopressin intranasal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesJapan
- Study dates
- Jan 2011to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Toranomon Hospital
Minato, Tokyo
Aichi Medical University
Nagakute, Aichi, Aichi-ken
Nagoya University Hospital
Nagoya, Aichi-ken
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka
Saitama Medical Center Jichi Medical University
Saitama, Saitama
About this study
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
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
- Being tested
- Desmopressin Oral Melt, Desmopressin intranasal
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Insipidus, Neurogenic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin Oral MeltDrug
Also called Minirin, FE992026
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 intranasalDrug
Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | 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. Receives: Drug: Desmopressin Oral Melt; Drug: Desmopressin intranasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 24-hour Urine Volume
Measured: Day 0, Week 4
Secondary outcomes (7)
24-hour urine volume (mL)
Measured: Day 0, Week 4
Hourly diuresis rate (mL/hr)
Measured: Day 0, Week 4
Urine osmolality (mOsm/kg)
Measured: Day 0, Week 4
Urine specific gravity (g/mL)
Measured: Day 0, Week 4
Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity
Measured: Day 0, Week 4
Serum sodium level
Measured: up to Month 13
Participants with Adverse Events Summarized by Incidence and Severity
Includes abnormal lab values and vital signs
Measured: up to Month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Diabetes InsipidusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280188
- Sponsor's protocol ID
- FE992026 CS43
- Status last verified
- Aug 2012
- First submitted
- 19 Jan 2011
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23811987
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01280188
- Acronym / sponsor ID
- FE992026 CS43
- Conditions
- Central Diabetes Insipidus
- Keywords
- Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: Desmopressin Oral Melt, Drug: Desmopressin intranasalDay 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. |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must be documented to have Central Diabetes Insipidus (CDI) by at least two of the following four criteria (a-d):
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desmopressin Oral MeltAlso: Minirin, FE992026Oral 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. | Drug | Desmopressin |
| Desmopressin intranasalSelf-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1 | Drug | Desmopressin |
Primary outcome
Change from Baseline in 24-hour Urine Volume
Time frame: Day 0, Week 4
7 secondary outcomes
24-hour urine volume (mL)
Time frame: Day 0, Week 4
Hourly diuresis rate (mL/hr)
Time frame: Day 0, Week 4
Urine osmolality (mOsm/kg)
Time frame: Day 0, Week 4
Urine specific gravity (g/mL)
Time frame: Day 0, Week 4
Percentage of participants within normal range for urinary output, urinary osmolality and urine specific gravity
Time frame: Day 0, Week 4
Serum sodium level
Time frame: up to Month 13
Participants with Adverse Events Summarized by Incidence and Severity
Time frame: up to Month 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2012.
- Derived from this study: PubMed 23811987Arima 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopressin Oral Melt and Desmopressin intranasal in people with Central Diabetes Insipidus, run by Ferring Pharmaceuticals at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 24-hour Urine Volume (time frame: Day 0, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01280188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2012.