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NCT02216214 Clinical Trial

Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Overactive Bladder (OAB) Clinical Trial

— PILLAR  

Official title:
A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02216214
Other study ID # 178-MA-1005
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 7, 2014
Est. completion date January 2, 2018

Study information
Verified date January 2021
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mirabegron
oral tablet
• Placebo
oral tablet
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Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Global Development, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours 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. Baseline and EOT (up to 12 weeks)
Primary Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Mean Volume Voided Per Micturition The mean volume voided per micturition during 3 days of the 3-day micturition diary period. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC) 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours 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. Baseline and EOT (up to 12 weeks)
Secondary Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Barthel Index of Daily Living Score 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in PPIUS The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in OAB-q HRQL Subscale Scores 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 Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items 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. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS) The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely). Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA) The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period. Baseline and Weeks 4, 8 and EOT (up to 12 weeks)
Secondary Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection. Baseline and EOT (up to 12 weeks)
Secondary Percentage of Participants Who Achieved Micturition Frequency Normalization Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline. End of treatment (up to 12 weeks)
Secondary Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit. End of treatment (up to 12 weeks)
Secondary Percentage of Participants With Zero Incontinence Episodes Per 24 Hours An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit. End of treatment (up to 12 weeks)
Secondary Percentage of Participants With = 10-Point Improvement From Baseline in OAB-q HRQL Subscales 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 Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with = 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit. End of treatment (up to 12 weeks)
Secondary Percentage of Participants With = 1-Point Improvement From Baseline in PPBC 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. Participants with = 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit. End of treatment (up to 12 weeks)
Secondary Percentage of Participants Major (= 2-Point) Improvement From Baseline in PPBC 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. Participants with = 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit. End of treatment (up to 12 weeks)
Secondary Number of Participants With Adverse Events (AEs) Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events. From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)
Secondary Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function. Baseline and EOT (up to 12 weeks)
Secondary Change From Baseline in Post-void Residual Volume (PVR) PVR was assessed by ultrasonography or bladder scan. Baseline and EOT (up to 12 weeks)
See also
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Terminated NCT04451382 - PTNS vs Botox of Refractory OAB
Terminated NCT04641975 - A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB) Phase 3
Completed NCT00366002 - Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder Phase 4
Completed NCT02138747 - A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB) Phase 4
Completed NCT03602508 - Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
Completed NCT03572231 - A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
Completed NCT05211193 - Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
Completed NCT04562090 - A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder Phase 4
Completed NCT00282932 - Detrol LA In Men With Overactive Bladder. Phase 4
Completed NCT01639794 - Vesitirim™ in Men Postmarketing Observational Study N/A
Completed NCT00742833 - A Phase II Study of KUC-7483 in Patients With Overactive Bladder Phase 2
Withdrawn NCT01317810 - A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication N/A

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