NocturiaPhase 4NCT01439997
Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
A Phase 4 study testing Desmopressin in people with Nocturia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Mar 2012to 1 Feb 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent prior to the performance of any study-related activity
- patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
- evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart
- Diuresis <2.5L
Who cannot join
- hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
- pregnancy
- genitourinary tract pathology (infection, tumor,...)
- urolithiasis
- suspicion or evidence of cardiac failure
- moderate to severe renal insufficiency (creatinin clearance < 60 ml/min)
Show all 11Show fewer
- psychogenic or habitual polydipsia
- hyponatraemia or predisposition for hyponatraemia
- diabetes insipidus
- syndrome of inadequate ADH production
- suspicion or evidence of liver failure
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:
- Are differences related to the pathophysiological factors involved in nocturia?
- Are there age/gender/size differences?
- Can the investigators identify patients who are likely to develop hyponatraemia?
- Can the investigators individualize treatment and reduce risk for hyponatraemia?
Read more
The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.
There are two groups of patients:
Group A:
Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).
Group B:
This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.
The study starts when the patients takes his first prescribed Minirin Melt tablet:
- On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
- On day 3 the patient has to give a urine sample.
- Patients have to fill out a frequency/volume chart during the first 14 days.
- On day 30, a 3rd blood sample will be taken
- Conditions
- Nocturia
- Being tested
- Desmopressin
- Keywords
- Nocturnal polyuria
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Minirin Melt 60 µg
Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin Melt Therapy in Nocturnal Polyuria Patients | Experimental | Not described Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.
Measured: At day 3 after first desmopressin intake.
Urine sample for urine concentration of Na+, K+, creatinin and osmolality
Measured: At day 3
Area Under Curve (AUC) frequency/volume chart during the first 14 days
Measured: Every day during the first 14 days.
The decrease of number of nocturnal micturition episodes.
Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.
Measured: At day 0
The decrease of the number of nocturnal micturition episodes.
Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
Measured: At day 30
Registration of number of side effects at day 3.
Measured: At day 3
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.
Measured: At day 7 after first desmopressin intake
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.
Measured: At day 30 after first desmopressin intake
Registration of number of side effects at day 7
Measured: At day 7
Registration of number of side effects at day 30.
Measured: At day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study start26 Mar 2012
- Primary completion1 Feb 2013
- Study completion1 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Everaert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439997
- Sponsor's protocol ID
- 2011/567
- Status last verified
- Dec 2022
- First submitted
- 14 Sep 2011
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desmopressin Melt Therapy in Nocturnal Polyuria Patients: Pharmacodynamic Study
- ClinicalTrials.gov ID
- NCT01439997
- Acronym / sponsor ID
- 2011/567
- Conditions
- Nocturia
- Keywords
- Nocturnal polyuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 26 Mar 2012 (actual)
- Primary completion
- 1 Feb 2013 (actual)
- Study completion
- 1 Feb 2015 (actual)
- First posted
- 23 Sep 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.
The objective of this study is to find out what the pharmacodynamic (PD) characteristics of desmopressin melt are in nocturia patients (compared to healthy volunteers and children). The main questions the investigators want to answer are:
- Are differences related to the pathophysiological factors involved in nocturia?
- Are there age/gender/size differences?
- Can the investigators identify patients who are likely to develop hyponatraemia?
- Can the investigators individualize treatment and reduce risk for hyponatraemia?
The patient will be given a prescription to buy Minirin Melt 60µg at the local pharmacy. During 30 days, the patient has to take Minirin Melt 60µg in the evening before going to bed.
There are two groups of patients:
Group A:
Patients that still have to undergo an evaluation phase, according to standard procedures (e.g. osmolality test, blood sample). This procedure is not a part of this study. The study starts when the 1st Minirin Melt tablet has been taken (= day 1).
Group B:
This group already went through the evaluation phase (by participation to study 1 or study 3 as mentioned above) and they have been prescribed Minirin Melt 60 µg ambulatory.
The study starts when the patients takes his first prescribed Minirin Melt tablet:
- On day 3 and day 7 a blood sample will be taken at the UZ Ghent for safety control (Na+, K+, creatinin, osmolality = good clinical practice guideline). These first 2 visits (day 3 and day 7) are standard procedure. If the patient is at high risk for side effects, blood has to be taken during the first 7 days.
- On day 3 the patient has to give a urine sample.
- Patients have to fill out a frequency/volume chart during the first 14 days.
- On day 30, a 3rd blood sample will be taken
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmopressin Melt Therapy in Nocturnal Polyuria Patients | Experimental | Drug: Desmopressin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written informed consent prior to the performance of any study-related activity
- patients, men and women, 18 years and older, with an average of ≥ 2 nocturnal voids per night
- evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart
- Diuresis <2.5L
Key exclusion criteria (11 listed)
- hypersensitivity/anaphylactic reaction on desmopressin or one of the other substances
- pregnancy
- genitourinary tract pathology (infection, tumor,...)
- urolithiasis
- suspicion or evidence of cardiac failure
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 |
|---|---|---|
| DesmopressinAlso: Minirin Melt 60 µgAdministration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate. | Drug | Desmopressin Melt Therapy in Nocturnal Polyuria Patients |
Primary outcome
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3.
Time frame: At day 3 after first desmopressin intake.
Urine sample for urine concentration of Na+, K+, creatinin and osmolality
Time frame: At day 3
Area Under Curve (AUC) frequency/volume chart during the first 14 days
Time frame: Every day during the first 14 days.
The decrease of number of nocturnal micturition episodes.
Time frame: At day 0
Questionnaires at day 0 to evaluate the decrease of number of nocturnal micturition episodes.
The decrease of the number of nocturnal micturition episodes.
Time frame: At day 30
Questionnaires at day 30 to evaluate the number of nocturnal micturition episodes
Registration of number of side effects at day 3.
Time frame: At day 3
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 7.
Time frame: At day 7 after first desmopressin intake
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 30.
Time frame: At day 30 after first desmopressin intake
Registration of number of side effects at day 7
Time frame: At day 7
Registration of number of side effects at day 30.
Time frame: At day 30
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 15 Dec 2022.
- Related InfoLink provided by the sponsor.
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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.
Karel Everaert, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desmopressin in people with Nocturia, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 11 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 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Blood samples for plasma concentration of Na+, K+, creatinin, osmolality (safety profile)at day 3. (time frame: At day 3 after first desmopressin intake.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.