Trial · NCT02751931
Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
NCT02751931, Phase 3, Completed, Astellas Pharma Europe B.V.; results first posted 2020-05-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity. Trials, record NCT02751931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02751931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
- NCT number
- NCT02751931
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Astellas Pharma Europe B.V.
- Conditions
- Neurogenic Detrusor Overactivity
- Interventions
- Mirabegron
- First posted
- 2016-04-26
- Last updated
- 2024-11-12
- Other registries' IDs
- eudract:2015-002876-25
- Results first posted
- 2020-05-12
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24 | Baseline and week 24 | Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. Missing MCC observations at week 24 were imputed using last observation carried forward (LOCF). |
| Secondary | Change From Baseline in Bladder Compliance (ΔV/ΔP) | Baseline and weeks 4 and 24 | Bladder compliance was an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder. Change from baseline in bladder compliance (change in volume/change in pressure) was assessed by the independent central reviewers and reported as annotations on the urodynamic trace and in an external database. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. |
| Secondary | Change From Baseline in Maximum Cystometric Capacity at Week 4 | Baseline and week 4 | Change from baseline in MCC was based on filling urodynamics (volume at the end of filling). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. |
| Secondary | Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling | Baseline and weeks 4 and 24 | Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. |
| Secondary | Change From Baseline in Detrusor Pressure at End of Filling | Baseline and weeks 4 and 24 | Detrusor pressure was defined as bladder pressure minus intra-abdominal pressure as assessed by urodynamics. Filling was stopped (end of filling) when the detrusor pressure exceeded 100 cm H2O or was considered dangerously high by the investigator or urodynamicist (for instance, a prolonged passive detrusor pressure \> 40 cm H2O). During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. |
| Secondary | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20) | Baseline and weeks 4 and 24 | Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of \> 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. |
| Secondary | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated Analysis | Baseline and weeks 4 and 24 | Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of \> 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. This updated analysis is presented as the original analysis of bladder volume until first detrusor contraction (\> 15 cm H2O) did not impute missing bladder volume data with the maximum cystometric capacity (MCC) value at that visit according to the statistical analysis plan (SAP). This analysis was updated to impute missing values for volume at first contraction with respective MCC values. |
| Secondary | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-test | Baseline and weeks 4 and 24 | Detrusor overactivity is the occurrence of involuntary detrusor contractions during filling cystometry. During urodynamic assessments, the bladder was filled until voiding/leakage began, or until the participant experienced pain or discomfort, or because dangerous high detrusor pressure, or 135% of maximum catheterized volume for age had been reached. A valid urodynamic assessment was confirmed valid by the central reviewers. If no detrusor contraction of \> 15 cm H2O occurred, the bladder volume was imputed with maximum cystometric capacity. |
| Secondary | Change From Baseline in Average Catheterized Volume Per Catheterization | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | For each participant, the average catheterized volume per catheterization was calculated as the sum of all available/non-missing catheterized volumes recorded over 2 measuring days in the weekend diary, whether or not the 2 days were consecutive divided by the number of catheterizations with non-missing volumes. If volumes were recorded on 1 single day of the weekend diary, the average catheterized volume per catheterization was calculated using all available/non-missing catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend diary, the average catheterized volume per catheterization was missing. A valid bladder diary day in the weekend diary was any e-diary day for which ≥1 catheterized volume \>0 mL was recorded with complete date and time. |
| Secondary | Change From Baseline in Maximum Catheterized Volume | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | For each participant, the maximum catheterized volume per day was calculated using all available/non-missing catheterized volumes recorded for the 2 measuring days in the weekend e-diary, whether or not these 2 days were consecutive. Maximum value was calculated separately for each measuring day and the mean of the two values was used. If volumes recorded on 1 single day of the weekend e-diary, the maximum catheterized volume per day was calculated using all available/non-zero catheterized volumes recorded that day. If no volumes were recorded on any day of the weekend e-diary, the maximum catheterized volume per day was missing. A valid bladder diary day in the weekend diary was any e-diary day for which \>=1 catheterized volume \>0 mL was recorded with complete date and time. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24 | Baseline and week 24 | The analysis population consisted of the full analysis set (FAS) which included all participants who took ≥ 1 dose of study drug and provided both valid (as by the central reviewer's assessment) nonmissing MCC measurements at baseline and at a postbaseline visit for the primary efficacy endpoint. | mL | MEAN |
| SECONDARY | Change From Baseline in Bladder Compliance (ΔV/ΔP) | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL/cm H2O | MEAN |
| SECONDARY | Change From Baseline in Maximum Cystometric Capacity at Week 4 | Baseline and week 4 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies those who where evaluable for this outcome measure. | mL | MEAN |
| SECONDARY | Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | overactive detrusor contractions | MEAN |
| SECONDARY | Change From Baseline in Detrusor Pressure at End of Filling | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | cm H2O | MEAN |
| SECONDARY | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20) | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEDIAN |
| SECONDARY | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Wilcoxon Signed-rank Test Updated Analysis | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEDIAN |
| SECONDARY | Change From Baseline in Filling Bladder Volume Until First Overactive Detrusor Contraction (> 15 cm H20): Paired T-test | Baseline and weeks 4 and 24 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
| SECONDARY | Change From Baseline in Average Catheterized Volume Per Catheterization | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
| SECONDARY | Change From Baseline in Maximum Catheterized Volume | Baseline and weeks 2, 4, 8, 12, 24, 36 and 52 | The analysis population consisted of the FAS. Here, Overall Number of participants analyzed signifies number of participants evaluable for this outcome measure and number analyzed signifies number of participants with available data at each time point. | mL | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group384
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24 | Children (3 to < 12 Years) | 72.09 | Standard Deviation 87.09 | mL | |
| Change From Baseline in Maximum Cystometric Capacity (MCC) at Week 24 | Adolescents (12 to < 18 Years) | 113.21 | Standard Deviation 82.99 | mL | |
| Change From Baseline in Bladder Compliance (ΔV/ΔP) | Children (3 to < 12 Years) | Change at Week 4 | -4.09 | Standard Deviation 50.78 | mL/cm H2O |
| Change From Baseline in Bladder Compliance (ΔV/ΔP) | Adolescents (12 to < 18 Years) | Change at Week 4 | 15.16 | Standard Deviation 22.69 | mL/cm H2O |
| Change From Baseline in Bladder Compliance (ΔV/ΔP) | Children (3 to < 12 Years) | Change at Week 24 | 14.62 | Standard Deviation 42.09 | mL/cm H2O |
| Change From Baseline in Bladder Compliance (ΔV/ΔP) | Adolescents (12 to < 18 Years) | Change at Week 24 | 13.59 | Standard Deviation 15.02 | mL/cm H2O |
| Change From Baseline in Maximum Cystometric Capacity at Week 4 | Children (3 to < 12 Years) | 41.36 | Standard Deviation 71.64 | mL | |
| Change From Baseline in Maximum Cystometric Capacity at Week 4 | Adolescents (12 to < 18 Years) | 80.78 | Standard Deviation 96.15 | mL | |
| Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling | Children (3 to < 12 Years) | Change at Week 4 | 0.44 | Standard Deviation 5.82 | overactive detrusor contractions |
| Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cm H20) Until End of Filling | Adolescents (12 to < 18 Years) | Change at Week 4 | -0.64 | Standard Deviation 2.94 | overactive detrusor contractions |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Children (3 to < 12 Years) | 56 | |
| Overall Study | STARTED | Adolescents (12 to < 18 Years) | 35 | |
| Overall Study | Treated | Children (3 to < 12 Years) | 55 | |
| Overall Study | Treated | Adolescents (12 to < 18 Years) | 31 | |
| Overall Study | COMPLETED | Children (3 to < 12 Years) | 43 | |
| Overall Study | COMPLETED | Adolescents (12 to < 18 Years) | 27 | |
| Overall Study | NOT COMPLETED | Children (3 to < 12 Years) | 13 | |
| Overall Study | NOT COMPLETED | Adolescents (12 to < 18 Years) | 8 |
Source ClinicalTrials.gov
Adverse events52
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 | Constipation | Gastrointestinal disorders | Children (3 to < 12 Years) | 3 | 55 | 3 |
| other | Constipation | Gastrointestinal disorders | Adolescents (12 to < 18 Years) | 1 | 31 | 1 |
| other | Pyrexia | General disorders | Children (3 to < 12 Years) | 2 | 55 | 2 |
| other | Pyrexia | General disorders | Adolescents (12 to < 18 Years) | 2 | 31 | 2 |
| other | Escherichia urinary tract infection | Infections and infestations | Children (3 to < 12 Years) | 3 | 55 | 5 |
| other | Escherichia urinary tract infection | Infections and infestations | Adolescents (12 to < 18 Years) | 5 | 31 | 6 |
| other | Nasopharyngitis | Infections and infestations | Children (3 to < 12 Years) | 3 | 55 | 3 |
| other | Nasopharyngitis | Infections and infestations | Adolescents (12 to < 18 Years) | 2 | 31 | 2 |
| other | Respiratory tract infection viral | Infections and infestations | Children (3 to < 12 Years) | 4 | 55 | 6 |
| other | Respiratory tract infection viral | Infections and infestations | Adolescents (12 to < 18 Years) | 0 | 31 | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Children (3 to < 12 Years) | 0 | 55 |
| Total, all-cause mortality | Adolescents (12 to < 18 Years) | 0 | 31 |
| Total, other adverse events | Children (3 to < 12 Years) | 17 | 55 |
| Total, other adverse events | Adolescents (12 to < 18 Years) | 9 | 31 |
| Total, serious adverse events | Children (3 to < 12 Years) | 9 | 55 |
| Total, serious adverse events | Adolescents (12 to < 18 Years) | 5 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34058027 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Children (3 to < 12 Years) vs Adolescents (12 to < 18 Years): deaths from any cause | Trial comparisons |
| Children (3 to < 12 Years) vs Adolescents (12 to < 18 Years): serious adverse events | 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/NCT02751931
GET https://conductscience.org/api/trials/v1/NCT02751931/registered?page=2