NocturiaPhase 2DAISSNCT01779466
Daytime Impact Sleep Study
A Phase 2 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 1 site in United Kingdom.
Trial summary
This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Jun 2014
- Phase
- Phase 2
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 2 night time voids per night
- Habitual sleep of 6-9.5 hours per night
- Experiencing symptoms of Nocturia greater than 6 months
Who cannot join
- Greater than 10 night time voids
- History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)
- Other sleep disorders
- Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence
- Urological malignancies
- Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.)
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- Central or nephrogenic diabetes insipidus
- Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs)
- Syndrome of inappropriate antidiuretic hormone (SIADH)
- Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Hyponatraemia with sodium <135 mmol/L
- Renal insufficiency
- Known or suspected clinically significant hepatic and/or biliary diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo
This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.
- Conditions
- Nocturia
- Being tested
- Desmopressin, Placebo (not active)
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Placebo (not active)Drug
| Study group | Role | What they receive |
|---|---|---|
| Experimental A | Experimental | Not described Receives: Drug: Desmopressin |
| Experimental B | Experimental | Not described Receives: Drug: Desmopressin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (not active) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of nocturnal voids
As measured by voiding diary
Measured: 1 month and 3 months
Wake after sleep onset
i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
Measured: 1 month and 3 months
Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale
Daytime performance
Measured: 1 month and 3 months
Mean time to first void
As measured by voiding diary
Measured: 1 month and 3 months
Sleep efficiency
Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography
Measured: 1 month and 3 months
Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time
Measured by Polysomnography
Measured: 1 month and 3 months
Number of awakenings due to nocturia
Measured by Polysomnography
Measured: 1 month and 3 months
Latency to slow-wave sleep
Measured by Polysomnography
Measured: 1 month and 3 months
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
Measured by Actigraphy
Measured: 1 month and 3 months
Percent of sleep
Measured by Actigraphy
Measured: 1 month and 3 months
Number of awakenings due to nocturia
Measured by Actigraphy
Measured: 1 month and 3 months
Quality of life score measured by EQ-5D-5L
Daytime performance
Measured: 1 month and 3 months
Safety - incidence of adverse events
Measured: 1 month and 3 months
Safety - clinically significant changes in lab values
Measured: 1 week and 3 months
Safety - clinically significant changes in vital signs
Measured: 1 week, 1 month and 3 months
Safety - clinically significant changes in physical examination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Terminated due to lack of eligible patients
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5 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
- NCT01779466
- Sponsor's protocol ID
- 000088
- Other IDs
- 2012-004388-34
- Acronym
- DAISS
- Status last verified
- Apr 2015
- First submitted
- 23 Jan 2013
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo
- ClinicalTrials.gov ID
- NCT01779466
- Acronym / sponsor ID
- DAISS / 000088
- Conditions
- Nocturia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of eligible patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jan 2013 (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 trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental A | Experimental | Drug: Desmopressin |
| Experimental B | Experimental | Drug: Desmopressin |
| Placebo | Placebo comparator | Drug: Placebo (not active) |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 2 night time voids per night
- Habitual sleep of 6-9.5 hours per night
- Experiencing symptoms of Nocturia greater than 6 months
Key exclusion criteria (15 listed)
- Greater than 10 night time voids
- History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)
- Other sleep disorders
- Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence
- Urological malignancies
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 | Drug | Experimental A, Experimental B |
| Placebo (not active) | Drug | Placebo |
Primary outcome
Mean number of nocturnal voids
Time frame: 1 month and 3 months
As measured by voiding diary
Wake after sleep onset
Time frame: 1 month and 3 months
i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale
Time frame: 1 month and 3 months
Daytime performance
Mean time to first void
Time frame: 1 month and 3 months
As measured by voiding diary
Sleep efficiency
Time frame: 1 month and 3 months
Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography
Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time
Time frame: 1 month and 3 months
Measured by Polysomnography
Number of awakenings due to nocturia
Time frame: 1 month and 3 months
Measured by Polysomnography
Latency to slow-wave sleep
Time frame: 1 month and 3 months
Measured by Polysomnography
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
Time frame: 1 month and 3 months
Measured by Actigraphy
Percent of sleep
Time frame: 1 month and 3 months
Measured by Actigraphy
Number of awakenings due to nocturia
Time frame: 1 month and 3 months
Measured by Actigraphy
Quality of life score measured by EQ-5D-5L
Time frame: 1 month and 3 months
Daytime performance
Safety - incidence of adverse events
Time frame: 1 month and 3 months
Safety - clinically significant changes in lab values
Time frame: 1 week and 3 months
Safety - clinically significant changes in vital signs
Time frame: 1 week, 1 month and 3 months
Safety - clinically significant changes in physical examination
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Terminated due to lack of eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 1 site in United Kingdom.
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 3 inclusion and 15 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: stopped early, as of the sponsor's last update on 27 Apr 2015. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Terminated due to lack of eligible patients). Results are not available in the source record.
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?
Mean number of nocturnal voids (time frame: 1 month and 3 months). The study lists 16 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 27 Apr 2015.