Nocturnal PolyuriaPhase 4NCT01435083
Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
A Phase 4 study testing Desmopressin in people with Nocturnal Polyuria, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The objective of this study is to find out what the pharmacokinetic/dynamic (PK/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
- Nocturnal Polyuria
- 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
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Jul 2013
- 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 woman, 18 years and older, with nocturnal polyuria, resulting in nocturia (2 voids or more at night) and/or nocturnal incontinence.
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 < 50 ml/min)
Show all 10Show fewer
- psychogenic or habitual polydipsia
- hyponatraemia or predisposition for hyponatraemia
- diabetes insipidus
- syndrome of inadequate ADH production
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to find out what the pharmacokinetic/dynamic (PK/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
Day 1:
- Patient is being hospitalized in the morning
- General anamnesis and clinical examination
- Uroflow and residue measurements (3x)
- Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin
Day 1-2:
- In the evening at 20h:
- start (with empty bladder!) 24h miction-incontinence-residue registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
- Measurement of blood pressure during 24h
Day 2-3:
- In the evening at 19h (day 2): drink 15mL/kg water
- At 20h: take desmopressin melt 120µg + start:
- 24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)
- Measurement of blood pressure during 24h
- Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake
- Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile)
- At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h
- Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days
- Conditions
- Nocturnal Polyuria
- Being tested
- Desmopressin
- Keywords
- Nocturia
- 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 120 µg, H01BA02
120 µg, oral lyophilisate, sublingual use
| Study group | Role | What they receive |
|---|---|---|
| nocturnal polyuria patient with desmopressin MELT | Experimental | Not described Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults
- blood analysis for plasma concentration of desmopressin: 1h, 2h, 3h, 6h and 12h after drug intake
- urine analysis for urinary concentration of sodium, potassium, creatinin and osmolality:
- after water load with 15ml/kg body weight (evening day 2): the moment of drug intake, 1h, 2h, 3h, 6h and 12h after drug intake
- after water load with 15ml/kg body weight (morning day 3): 1h, 2h, 3h after water load
Measured: hospitalisation of 3 days of which 15h specific for primary outcome measurements
Secondary outcomes (2)
24h miction-incontinence-residue registration: urine collections every 3 hours
24h miction-incontinence-residu registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with:
- Registration of volumes
- Measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
Measured: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
Measurement of blood pressure during 24h
Measured: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal PolyuriaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT01435083
- Sponsor's protocol ID
- 2011/566
- Status last verified
- Dec 2014
- First submitted
- 13 Sep 2011
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desmopressin Melt Therapy in Patients With Nocturnal Polyuria: a Pharmacokinetic/Dynamic Study
- ClinicalTrials.gov ID
- NCT01435083
- Acronym / sponsor ID
- 2011/566
- Conditions
- Nocturnal Polyuria
- Keywords
- Nocturia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 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 pharmacokinetic/dynamic (PK/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?
Day 1:
- Patient is being hospitalized in the morning
- General anamnesis and clinical examination
- Uroflow and residue measurements (3x)
- Sober blood sample, to determine plasma concentrations of Na+, Cl-, osmolality and creatinin
Day 1-2:
- In the evening at 20h:
- start (with empty bladder!) 24h miction-incontinence-residue registration: urine collections every 3 hours (every portion of urine within a period of 3 hours must be collected in the same collection device), with: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin
- Measurement of blood pressure during 24h
Day 2-3:
- In the evening at 19h (day 2): drink 15mL/kg water
- At 20h: take desmopressin melt 120µg + start:
- 24h miction-incontinence-residue registration: registration of volumes and measurement urinary concentrations of Na+, Cl-, osmolality and creatinin (U1-U7)
- Measurement of blood pressure during 24h
- Collection of urine:U1 at 19h, U2 at 20h, together with intake of first desmopressin melt, U3 at 21h = 1h after desmopressin melt intake, U4 at 22h = 2 after desmopressin melt intake,U5 at 23h = 3h after desmopressin melt intake, U6 at 2h (day 3) = 6h after desmopressin melt intake, U7 at 8h = 12h after desmopressin melt intake
- Blood samples for blood levels of desmopressin: 1h, 2h, 3h, 6h after desmopressin melt intake, 12h after desmopressin melt intake + plasma concentrations of Na+, Cl-, osmolality and creatinin (safety profile)
- At 8h in the morning (day 3): drink 15mL/kg water + collection of urine per hour during 3h with measurement of urinary concentrations of Na+, Cl-, osmolality and creatinin: U8 at 9h, U9 at 10h, U10 at 11h
- Patient can go home on day 3, unless he is at high risk for side effects, high-risk patients are hospitalized for 7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nocturnal polyuria patient with desmopressin MELT | 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 (2 listed)
- written informed consent prior to the performance of any study-related activity
- patients, men and woman, 18 years and older, with nocturnal polyuria, resulting in nocturia (2 voids or more at night) and/or nocturnal incontinence.
Key exclusion criteria (10 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 120 µg, H01BA02120 µg, oral lyophilisate, sublingual use | Drug | nocturnal polyuria patient with desmopressin MELT |
Primary outcome
Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults
Time frame: hospitalisation of 3 days of which 15h specific for primary outcome measurements
* blood analysis for plasma concentration of desmopressin: 1h, 2h, 3h, 6h and 12h after drug intake * urine analysis for urinary concentration of sodium, potassium, creatinin and osmolality: * after water load with 15ml/kg body weight (evening day 2): the moment of drug intake, 1h, 2h, 3h, 6h and 12h after drug intake * after water load with 15ml/kg body weight (morning day 3): 1h, 2h, 3h after water load
2 secondary outcomes
24h miction-incontinence-residue registration: urine collections every 3 hours
Time frame: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
Measurement of blood pressure during 24h
Time frame: 2x 24h: day 1 19h - day 2 19h ; day 2 20h - day 3 20h
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 5 Dec 2014.
- 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 Nocturnal Polyuria, 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 2 inclusion and 10 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 5 Dec 2014. 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?
Pharmacokinetic and dynamic evaluation of desmopressin melt for treatment of nocturnal polyuria in adults (time frame: hospitalisation of 3 days of which 15h specific for primary outcome measurements). 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 5 Dec 2014.