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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Number of Wet Nights Between Baseline and Treatment Period II | 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. |
| Secondary | Change in Number of Wet Nights Between Baseline and Treatment Period I | Baseline (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. |
| Secondary | Change in Number of Wet Nights Between Treatment Periods I and II | Treatment 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Number of Wet Nights Between Baseline and Treatment Period II | Baseline (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 nights | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Number of Wet Nights Between Baseline and Treatment Period I | Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation). | The Full analysis set. | wet nights | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Number of Wet Nights Between Treatment Periods I and II | Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4) | The full analysis set. | wet nights | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Number of Wet Nights Between Baseline and Treatment Period II | Desmopressin | 3.264 | 95% Confidence Interval 2.126 to 4.402 | wet nights | |
| Change in the Number of Wet Nights Between Baseline and Treatment Period II | Placebo | 1.451 | 95% Confidence Interval 0.333 to 2.570 | wet nights | |
| Change in Number of Wet Nights Between Baseline and Treatment Period I | Desmopressin | 2.946 | 95% Confidence Interval 1.815 to 4.078 | wet nights | |
| Change in Number of Wet Nights Between Baseline and Treatment Period I | Placebo | 1.317 | 95% Confidence Interval 0.205 to 2.428 | wet nights | |
| Change in Number of Wet Nights Between Treatment Periods I and II | Desmopressin | 0.318 | 95% Confidence Interval -0.653 to 1.289 | wet nights | |
| Change in Number of Wet Nights Between Treatment Periods I and II | Placebo | 0.135 | 95% Confidence Interval -0.819 to 1.088 | wet nights |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period I | STARTED | Desmopressin | 45 | |
| Treatment Period I | STARTED | Placebo | 44 | |
| Treatment Period I | Full Analysis Set | Desmopressin | 44 | |
| Treatment Period I | Full Analysis Set | Placebo | 44 | |
| Treatment Period I | COMPLETED | Desmopressin | 45 | |
| Treatment Period I | COMPLETED | Placebo | 44 | |
| Treatment Period I | NOT COMPLETED | Desmopressin | 0 | |
| Treatment Period I | NOT COMPLETED | Placebo | 0 | |
| Treatment Period II | STARTED | Desmopressin | 45 | |
| Treatment Period II | STARTED | Placebo | 44 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Empyema | Infections and infestations | Desmopressin | 0 | 45 | |
| other | Empyema | Infections and infestations | Placebo | 1 | 44 | |
| other | Nasopharyngitis | Infections and infestations | Desmopressin | 6 | 45 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 44 | |
| other | Tonsillitis | Infections and infestations | Desmopressin | 1 | 45 | |
| other | Tonsillitis | Infections and infestations | Placebo | 0 | 44 | |
| other | Upper respiratory tract infection | Infections and infestations | Desmopressin | 1 | 45 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 0 | 44 | |
| other | Headache | Nervous system disorders | Desmopressin | 1 | 45 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 44 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Desmopressin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Desmopressin | 18 | 45 |
| Total, other adverse events | Placebo | 14 | 44 |
| Total, serious adverse events | Desmopressin | 0 | 45 |
| Total, serious adverse events | Placebo | 0 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40728007 | DERIVED |
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 |
Source Trial comparisons
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.
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