Trial · NCT04641975
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
NCT04641975, Phase 3, Terminated, Astellas Pharma Global Development, Inc.; results first posted 2023-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB). Trials, record NCT04641975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04641975
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
- NCT number
- NCT04641975
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 26 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
- Interventions
- Mirabegron, Placebo
- First posted
- 2020-11-24
- Last updated
- 2024-11-14
- Other registries' IDs
- eudract:2016-001767-37
- Results first posted
- 2023-12-28
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 7-day micturition diary period. The analysis was performed with imputation of missing visit 7/week 12 data using the last observation carried forward (LOCF) method. |
| Secondary | Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Mean volume voided was derived from "Pee Volume" of the 2-day Weekend Episodic Diary. Mean volume voided per day was calculated as the sum of the volumes voided on that (valid diary) day divided by the number of times a volume was recorded on that day in the 2-day Weekend Episodic Diary. The analysis was performed with LOCF and without LOCF method. |
| Secondary | Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years | Baseline, week 12 | MVV data was derived from "Pee Volume" of the 2-day Weekend Episodic Diary. The MVV was the largest (non-zero) volume recorded over both of the 2 (valid) measuring days in the diary. The analysis was performed with LOCF and without LOCF method. |
| Secondary | Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | A daytime incontinence episode was defined as the complaint of any involuntary leakage of urine during daytime hours. Daytime was defined as time between waking up in the morning and going to sleep later the same day or next day. The mean number of daytime incontinence episodes per 24 hours was calculated by taking the sum of all daytime urinary incontinence episodes recorded in the participant diary, divided by the number of valid diary days. The analysis was performed with LOCF and without LOCF method. |
| Secondary | Change From Baseline to Week 12/EoT in Mean Number of Nighttime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | A nighttime incontinence episode was defined as the complaint of any involuntary leakage of urine during nighttime hours. Nightime was defined as time between between going to sleep on a day and waking up on the same or next day. The mean number of nighttime incontinence episodes per 24 hours was calculated by taking the sum of all nighttime urinary incontinence episodes recorded in the participant diary, divided by the number of valid diary days. The analysis was performed with LOCF and without LOCF method. |
| Secondary | Change From Baseline to Week 12/EoT in Mean Number of Daytime Micturitions Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | For a week day the daytime micturitions was derived from "Number of Times using the Toilet During the Day" was entered into the 5-day Week Diary. For a weekend day the daytime micturitions was derived from the number of times a "Pee in Toilet" or a "Pee in Toilet and Leakage" was entered into the 2-day Weekend Episodic Diary between the time the participant woke-up (exclusive). The total number of micturitions per weekend day was equal to the total number of times, in the diary, an amount of pee was recorded during daytime for that day. For each participant, the mean number of daytime micturitions was calculated as: Sum of the Number of Daytime Micturitions (per day) over the Valid Diary Days prior to Visit/Number of Valid Diary Days. The analysis was performed with LOCF and without LOCF method. |
| Secondary | Change From Baseline to Week 12/EoT in Number of Dry (Incontinence-free) Days Per 7 Days for Age Group 5 to <12 Years | Baseline, week 12 | A dry (incontinence free) day was defined as a day where the response is "Dry" to the question "How was your Day" and to "How was your Night". For a weekend day a "Dry (incontinence free) Day" was defined a day where no "New pee or leakage" was reported. Let Ddry be the number of valid diary days where the response to both questions was "Dry". Let Dwet be the number of valid diary days where the response to one of the two questions or to both questions was "Wet". If (Ddry + Dwet) \> 3, the number of dry days per 7 days was calculated as Ddry/(Ddry + Dwet)\* 7, otherwise the value was missing. The analysis was performed with LOCF and without LOCF method. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose up to week 14 | An AE was any untoward medical occurrence in a participant administered a study drug and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted a congenital anomaly/birth defect or other medically important event. A TEAE was defined as an AE observed after starting administration of the study drug until 30 days after last dose. |
| Secondary | Change From Baseline in Post Void Residual (PVR) Volume | Baseline, weeks 4, 12, 14 | PVR was assessed by ultrasonography. |
| Secondary | Number of Participants With Study Drug Acceptability and Palatability for Tablets | Week 12 | Participants evaluated the taste of the study drug/tablets by ticking 1 of the following categories: "Really Bad" (0), "Bad" (1), "Not Bad, Not Good" (2), "Good" (3) \& "Really Good" (4). Participants evaluated the swallow of the study drug/tablets by ticking one of the following categories: "Really Difficult" (0), "Difficult" (1), "Not Difficult, Not Easy" (2), "Easy" (3) and "Really Easy" (4). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis set: All participants who were randomized and received at least 1 dose of study drug and had at least 1 post baseline measurement for mean number of micturitions per 24 hours. | micturitions per 24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | milliliter (mL)/24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | mL | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | incontinence episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Number of Nighttime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set. | incontinence episodes per 24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Mean Number of Daytime Micturitions Per 24 Hours for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set | micturitions per 24 hours | MEAN |
| SECONDARY | Change From Baseline to Week 12/EoT in Number of Dry (Incontinence-free) Days Per 7 Days for Age Group 5 to <12 Years | Baseline, week 12 | Full Analysis Set with available data was analyzed. | incontinence-free days | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | From first dose up to week 14 | SAF | Participants | NUMBER |
| SECONDARY | Change From Baseline in Post Void Residual (PVR) Volume | Baseline, weeks 4, 12, 14 | SAF with available data was analyzed. | mL | MEAN |
| SECONDARY | Number of Participants With Study Drug Acceptability and Palatability for Tablets | Week 12 | SAF with available data was analyzed. | Participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years | Mirabegron (5 to < 12 Years) | -1.62 | Standard Error 0.89 | micturitions per 24 hours | |
| Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years | Placebo (5 to < 12 Years) | -3.84 | Standard Error 0.89 | micturitions per 24 hours | |
| Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years | Mirabegron (5 to < 12 Years) | Week 12 (without LOCF) | 18.38 | Standard Deviation 33.67 | milliliter (mL)/24 hours |
| Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years | Placebo (5 to < 12 Years) | Week 12 (without LOCF) | 24.55 | Standard Deviation 32.32 | milliliter (mL)/24 hours |
| Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years | Mirabegron (5 to < 12 Years) | Week 12 (with LOCF) | 18.38 | Standard Deviation 33.67 | milliliter (mL)/24 hours |
| Change From Baseline to Week 12/EoT in Mean Volume Voided Per 24 Hours for Age Group 5 to <12 Years | Placebo (5 to < 12 Years) | Week 12 (with LOCF) | 24.55 | Standard Deviation 32.32 | milliliter (mL)/24 hours |
| Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years | Mirabegron (5 to < 12 Years) | Week 12 (without LOCF) | 26.00 | Standard Deviation 51.46 | mL |
| Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years | Placebo (5 to < 12 Years) | Week 12 (without LOCF) | 26.38 | Standard Deviation 60.75 | mL |
| Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years | Mirabegron (5 to < 12 Years) | Week 12 (With LOCF) | 26.00 | Standard Deviation 51.46 | mL |
| Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years | Placebo (5 to < 12 Years) | Week 12 (With LOCF) | 26.38 | Standard Deviation 60.75 | mL |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mirabegron (5 to < 12 Years) | 11 | |
| Overall Study | STARTED | Placebo (5 to < 12 Years) | 12 | |
| Overall Study | STARTED | Mirabegron (12 to < 18 Years) | 2 | |
| Overall Study | STARTED | Placebo (12 to < 18 Years) | 1 | |
| Overall Study | COMPLETED | Mirabegron (5 to < 12 Years) | 9 | |
| Overall Study | COMPLETED | Placebo (5 to < 12 Years) | 10 | |
| Overall Study | COMPLETED | Mirabegron (12 to < 18 Years) | 1 | |
| Overall Study | COMPLETED | Placebo (12 to < 18 Years) | 0 | |
| Overall Study | NOT COMPLETED | Mirabegron (5 to < 12 Years) | 2 | |
| Overall Study | NOT COMPLETED | Placebo (5 to < 12 Years) | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events92
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 | Abdominal pain upper | Gastrointestinal disorders | Mirabegron(5 to<12 Years) | 0 | 11 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo (5 to < 12 Years) | 1 | 12 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Mirabegron(12 to<18 Years) | 0 | 2 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo (12 to < 18 Years) | 0 | 1 | 0 |
| other | Constipation | Gastrointestinal disorders | Mirabegron(5 to<12 Years) | 0 | 11 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo (5 to < 12 Years) | 1 | 12 | 2 |
| other | Constipation | Gastrointestinal disorders | Mirabegron(12 to<18 Years) | 0 | 2 | 0 |
| other | Constipation | Gastrointestinal disorders | Placebo (12 to < 18 Years) | 0 | 1 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Mirabegron(5 to<12 Years) | 0 | 11 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Placebo (5 to < 12 Years) | 1 | 12 | 1 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirabegron(5 to<12 Years) | 0 | 11 |
| Total, all-cause mortality | Placebo (5 to < 12 Years) | 0 | 12 |
| Total, all-cause mortality | Mirabegron(12 to<18 Years) | 0 | 2 |
| Total, all-cause mortality | Placebo (12 to < 18 Years) | 0 | 1 |
| Total, other adverse events | Mirabegron(5 to<12 Years) | 5 | 11 |
| Total, other adverse events | Placebo (5 to < 12 Years) | 7 | 12 |
| Total, other adverse events | Mirabegron(12 to<18 Years) | 1 | 2 |
| Total, other adverse events | Placebo (12 to < 18 Years) | 1 | 1 |
| Total, serious adverse events | Mirabegron(5 to<12 Years) | 0 | 11 |
| Total, serious adverse events | Placebo (5 to < 12 Years) | 0 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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