Trial · NCT02216214
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
NCT02216214, Phase 4, Completed, Astellas Pharma Global Development, Inc.; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB). Trials, record NCT02216214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02216214
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
- NCT number
- NCT02216214
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 888 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Overactive Bladder (OAB)
- Interventions
- Mirabegron, Placebo
- First posted
- 2014-08-13
- Last updated
- 2024-11-22
- Results first posted
- 2019-02-15
- Limitations and caveats
- Participants from one site were excluded from the FAS-I and SAF due to critical findings observed during a GCP audit of the site.
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours | Baseline and EOT (up to 12 weeks) | 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 3-day micturition diary period. |
| Primary | Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and EOT (up to 12 weeks) | An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period. |
| Secondary | Change From Baseline to EOT in Mean Volume Voided Per Micturition | Baseline and EOT (up to 12 weeks) | The mean volume voided per micturition during 3 days of the 3-day micturition diary period. |
| Secondary | Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score | Baseline and EOT (up to 12 weeks) | The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement. |
| Secondary | Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score | Baseline and EOT (up to 12 weeks) | The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement. |
| Secondary | Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC) | Baseline and EOT (up to 12 weeks) | The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. |
| Secondary | Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and EOT (up to 12 weeks) | Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period. |
| Secondary | Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and EOT (up to 12 weeks) | An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period. |
| Secondary | Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and EOT (up to 12 weeks) | A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period. |
| Secondary | Change From Baseline to EOT in Barthel Index of Daily Living Score | Baseline and EOT (up to 12 weeks) | The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
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 End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Particpants with available data at baseline and EOT are included in the analysis. Last observation carried forward (LOCF) was used for EOT. | micturitions/24 hours | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | incontinence episodes/24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EOT in Mean Volume Voided Per Micturition | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC) | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | urgency episodes/24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | urgency incontinence episodes/24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | nocturia episodes/24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to EOT in Barthel Index of Daily Living Score | Baseline and EOT (up to 12 weeks) | The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group78
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 End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours | Placebo | -1.7 | Standard Error 0.2 | micturitions/24 hours | |
| Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours | Mirabegron | -2.3 | Standard Error 0.2 | micturitions/24 hours | |
| Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours | Placebo | -1.45 | Standard Error 0.13 | incontinence episodes/24 hours | |
| Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours | Mirabegron | -2.00 | Standard Error 0.13 | incontinence episodes/24 hours | |
| Change From Baseline to EOT in Mean Volume Voided Per Micturition | Placebo | 17.45 | Standard Error 4.17 | mL | |
| Change From Baseline to EOT in Mean Volume Voided Per Micturition | Mirabegron | 30.54 | Standard Error 3.97 | mL | |
| Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score | Placebo | -18.69 | Standard Error 1.33 | units on a scale | |
| Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score | Mirabegron | -23.39 | Standard Error 1.29 | units on a scale | |
| Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score | Placebo | 14.80 | Standard Error 1.04 | units on a scale | |
| Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score | Mirabegron | 17.18 | Standard Error 1.01 | units on a scale |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 443 | |
| Overall Study | STARTED | Mirabegron | 445 | |
| Overall Study | Treated | Placebo | 442 | |
| Overall Study | Treated | Mirabegron | 445 | |
| Overall Study | COMPLETED | Placebo | 400 | |
| Overall Study | COMPLETED | Mirabegron | 409 | |
| Overall Study | NOT COMPLETED | Placebo | 43 | |
| Overall Study | NOT COMPLETED | Mirabegron | 36 |
Source ClinicalTrials.gov
Adverse events66
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 | Headache | Nervous system disorders | Placebo | 12 | 442 | 12 |
| other | Headache | Nervous system disorders | Mirabegron | 23 | 445 | 23 |
| serious | Acute myocardial infarction | Cardiac disorders | Placebo | 0 | 442 | 0 |
| serious | Acute myocardial infarction | Cardiac disorders | Mirabegron | 1 | 445 | 1 |
| serious | Angina pectoris | Cardiac disorders | Placebo | 1 | 442 | 1 |
| serious | Angina pectoris | Cardiac disorders | Mirabegron | 0 | 445 | 0 |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 0 | 442 | 0 |
| serious | Atrial fibrillation | Cardiac disorders | Mirabegron | 1 | 445 | 1 |
| serious | Diverticulum | Gastrointestinal disorders | Placebo | 0 | 442 | 0 |
| serious | Diverticulum | Gastrointestinal disorders | Mirabegron | 1 | 445 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 442 |
| Total, all-cause mortality | Mirabegron | 0 | 445 |
| Total, other adverse events | Placebo | 12 | 442 |
| Total, other adverse events | Mirabegron | 23 | 445 |
| Total, serious adverse events | Placebo | 12 | 442 |
| Total, serious adverse events | Mirabegron | 15 | 445 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Mirabegron vs Placebo: deaths from any cause | Trial comparisons |
| Mirabegron vs Placebo: 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/NCT02216214
GET https://conductscience.org/api/trials/v1/NCT02216214/registered?page=2