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Trial · NCT01078753

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

NCT01078753, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2011-11-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis. Trials, record NCT01078753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01078753

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis
NCT number
NCT01078753
Status
Completed
Phases
Phase 3
Enrollment
89 participants, actual
Lead sponsor
Ferring Pharmaceuticals
Conditions
Nocturnal Enuresis
Interventions
Desmopressin, Placebo
First posted
2010-03-02
Last updated
2011-11-02
Results first posted
2011-11-02

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in the Number of Wet Nights Between Baseline and Treatment Period IIBaseline (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.
SecondaryChange in Number of Wet Nights Between Baseline and Treatment Period IBaseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 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 I.
SecondaryChange in Number of Wet Nights Between Treatment Periods I and IITreatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)
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.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in the Number of Wet Nights Between Baseline and Treatment Period IIBaseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).The Full Analysis Set (FAS) included all participants who received at least one dose of study treatment, satisfied all the major eligibility criteria and for whom efficacy data was obtained.wet nightsLEAST_SQUARES_MEAN
SECONDARYChange in Number of Wet Nights Between Baseline and Treatment Period IBaseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).The Full analysis set.wet nightsLEAST_SQUARES_MEAN
SECONDARYChange in Number of Wet Nights Between Treatment Periods I and IITreatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)The full analysis set.wet nightsLEAST_SQUARES_MEAN

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in the Number of Wet Nights Between Baseline and Treatment Period IIDesmopressin3.26495% Confidence Interval 2.126 to 4.402wet nights
Change in the Number of Wet Nights Between Baseline and Treatment Period IIPlacebo1.45195% Confidence Interval 0.333 to 2.570wet nights
Change in Number of Wet Nights Between Baseline and Treatment Period IDesmopressin2.94695% Confidence Interval 1.815 to 4.078wet nights
Change in Number of Wet Nights Between Baseline and Treatment Period IPlacebo1.31795% Confidence Interval 0.205 to 2.428wet nights
Change in Number of Wet Nights Between Treatment Periods I and IIDesmopressin0.31895% Confidence Interval -0.653 to 1.289wet nights
Change in Number of Wet Nights Between Treatment Periods I and IIPlacebo0.13595% Confidence Interval -0.819 to 1.088wet nights

Participant flow16

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Treatment Period ISTARTEDDesmopressin45
Treatment Period ISTARTEDPlacebo44
Treatment Period IFull Analysis SetDesmopressin44
Treatment Period IFull Analysis SetPlacebo44
Treatment Period ICOMPLETEDDesmopressin45
Treatment Period ICOMPLETEDPlacebo44
Treatment Period INOT COMPLETEDDesmopressin0
Treatment Period INOT COMPLETEDPlacebo0
Treatment Period IISTARTEDDesmopressin45
Treatment Period IISTARTEDPlacebo44

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherEmpyemaInfections and infestationsDesmopressin045
otherEmpyemaInfections and infestationsPlacebo144
otherNasopharyngitisInfections and infestationsDesmopressin645
otherNasopharyngitisInfections and infestationsPlacebo644
otherTonsillitisInfections and infestationsDesmopressin145
otherTonsillitisInfections and infestationsPlacebo044
otherUpper respiratory tract infectionInfections and infestationsDesmopressin145
otherUpper respiratory tract infectionInfections and infestationsPlacebo044
otherHeadacheNervous system disordersDesmopressin145
otherHeadacheNervous system disordersPlacebo044

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityDesmopressin
Total, all-cause mortalityPlacebo
Total, other adverse eventsDesmopressin1845
Total, other adverse eventsPlacebo1444
Total, serious adverse eventsDesmopressin045
Total, serious adverse eventsPlacebo044

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
40728007DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Desmopressin vs Placebo: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01078753

GET https://conductscience.org/api/trials/v1/NCT01078753/events?page=2