Nocturnal EnuresisPhase 3PNENCT01078753
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
A Phase 3 study testing Desmopressin in people with Nocturnal Enuresis, run by Ferring Pharmaceuticals at 15 sites in Japan.
Trial summary
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality." Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Desmopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 15 sitesJapan
- Study dates
- Jan 2010to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
- Age 6 or above but under 16 regardless of gender
- Out-patient
- Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week
- Deemed healthy by the investigator
- Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol
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- Consent from the pediatric patient's legally acceptable representative
- Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility
- Show no possibility of being a nursing mother or pregnant, or becoming pregnant
- If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment
Who cannot join
- Suffer from enuresis with an underlying disease
- Participated in another clinical trial within six months preceding consent
- Used an intranasal Desmopressin in the past
- Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder
- Have an anomaly or a disease that may affect the oral absorption of drug products
- Hard to get cooperation from subject by school refusal, punishment or bullying
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- Deemed by the investigator to be inappropriate to participate in this trial
- Unable to be placed on water-intake restriction starting from two hours before bedtime
- Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Akita University Hospital
Akita, Akita
Showa Hospital
Amagasaki, Hyōgo
Kansai Medical University Hirakata Hospital
Hirakata, Osaka
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima
Shinko-Kakogawa Hospital
Kakogawa, Hyōgo
Tamura Children's Clinic
Mito, Ibaraki
Takesue Children's Clinic
Musashino, Tokyo
Juntendo University Nerima Hospital
Nerima City, Tokyo
Aikawa Station Clinic
Niigata, Niigata
Saitoh Pediatric Medical Clinic
Nishitōkyō, Tokyo
Kitano Hospital
Osaka, Osaka
Saitama Childrens Medical Centre
Saitama, Saitama
Shintoshin Child Clinic
Saitama, Saitama
Hoashi Children's Psychological Clinic
Setagaya City, Tokyo
Shinbo Child Clinic
Yokohama, Kanagawa
About this study
Official title: A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
- Conditions
- Nocturnal Enuresis
- Being tested
- Desmopressin, Placebo
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called FE992026, desmopressin melt, Minirin
Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.
PlaceboDrug
Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. Receives: Drug: Desmopressin |
| Placebo | Placebo comparator | Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Number of Wet Nights Between Baseline and Treatment Period II
The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.
Measured: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
Secondary outcomes (2)
Change in Number of Wet Nights Between Baseline and Treatment Period I
The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I.
Measured: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).
Change in Number of Wet Nights Between Treatment Periods I and II
The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II.
Measured: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 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
- NCT01078753
- Sponsor's protocol ID
- FE992026 CS35
- Acronym
- PNE
- Status last verified
- Sep 2011
- First submitted
- 1 Mar 2010
- Last updated
- 2 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.
PubMed 40728007
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Phase III Comparative Study With FE992026 in Children and Adolescents With Reduced Night-time Urinary Osmolarity-type Nocturnal Enuresis
- ClinicalTrials.gov ID
- NCT01078753
- Acronym / sponsor ID
- PNE / FE992026 CS35
- Conditions
- Nocturnal Enuresis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Posted 2 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: DesmopressinDuring treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
- Age 6 or above but under 16 regardless of gender
- Out-patient
- Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week
- Deemed healthy by the investigator
Key exclusion criteria (9 listed)
- Suffer from enuresis with an underlying disease
- Participated in another clinical trial within six months preceding consent
- Used an intranasal Desmopressin in the past
- Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder
- Have an anomaly or a disease that may affect the oral absorption of drug products
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: FE992026, desmopressin melt, MinirinDesmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime. | Drug | Desmopressin |
| PlaceboPlacebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime. | Drug | Placebo |
Primary outcome
Change in the Number of Wet Nights Between Baseline and Treatment Period II
Time frame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).
The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.
2 secondary outcomes
Change in Number of Wet Nights Between Baseline and Treatment Period I
Time frame: Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).
Change in Number of Wet Nights Between Treatment Periods I and II
Time frame: Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40728007Hahn D, Stewart F, Raman G. Desmopressin for nocturnal enuresis in children. Cochrane Database Syst Rev. 2025 Jul 29;7(7):CD002112. doi: 10.1002/14651858.CD002112.pub2.
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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
15 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 in people with Nocturnal Enuresis, run by Ferring Pharmaceuticals at 15 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 9 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 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. 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 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?
Yes. Results are posted in the registry (first posted 2 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in the Number of Wet Nights Between Baseline and Treatment Period II (time frame: Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).). 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 NCT01078753, 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 2 Nov 2011.