Trial · Interventional

CompletedPhase 3Results postedRegistry data

Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis

Short name PNE

NCTNCT01078753Other idFE992026 CS35

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 89 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Double masking
Countries: 1 country
Japan
Start: Jan 2010
Primary completion: Sept 2010
Completion: Sept 2010
First posted: 2 Mar 2010 (estimated)
Last update posted: 2 Nov 2011 (estimated)
Conditions: Nocturnal Enuresis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20102011

Ph 3
PNE
NCT01078753
Jan 2010 to Sept 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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."

Interventions

DesmopressinDrug
PlaceboDrug

Arms2

Experimental
Desmopressin
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.
Placebo comparator
Placebo
Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.

Primary outcomes1

Outcomes the sponsor listed as primary.

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).
Registry description
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.

Secondary outcomes(2)

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).
Registry description
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.
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)
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).

Change in the Number of Wet Nights Between Baseline and Treatment Period II

Group	Value (wet nights)
Desmopressin	3.264
Placebo	1.451

Secondary and other outcome results(2)

Secondary outcomeLeast squares mean· 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 Baseline and Treatment Period I

Group	Value (wet nights)
Desmopressin	2.946
Placebo	1.317

Secondary outcomeLeast squares mean· Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)

Change in Number of Wet Nights Between Treatment Periods I and II

Group	Value (wet nights)
Desmopressin	0.318
Placebo	0.135

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
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.	–	0 / 45	18 / 45
PlaceboParticipants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.	–	0 / 44	14 / 44

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedHahn 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. PMID 40728007

Eligibility

Who could join, as posted.

Sex: All
Age: from 6 Years up to 15 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.