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The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency and incontinence episodes.
The study consisted of two double-blind treatment periods with a wash-out period in between.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB: Mirabegron/Tolterodine ER | Experimental | In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. |
|
| BA: Tolterodine ER /Mirabegron | Experimental | In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. |
|
| AA: Mirabegron/Mirabegron | Experimental | In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period. |
|
| BB: Tolterodine ER /Tolterodine ER | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) | The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 ("strong preference for period 1," "mild preference for period 1," "no preference," "mild preference for period 2," "strong preference for period 2"). Participants who selected either a "mild preference" or "strong preference" were considered as having a preference for a specific study drug and participants who selected "no preference" were considered as having no preference for one study drug over the other study drug." |
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Inclusion Criteria:
Participant is willing and able to complete the micturition diary and questionnaires correctly.
Participant has symptoms of OAB (urinary frequency and urgency with or without incontinence) for greater than or equal to 3 months prior to Screening.
Participant must be treatment-naïve to pharmaceutical agents for OAB.
Female participant must not donate ova starting at Screening and throughout the study period, and for 30 days after the final study drug administration.
Male participant must not donate sperm starting at Screening and throughout the study period and for at least 30 days after final study drug administration.
Participant agrees not to participate in another interventional study from the time of screening until the final study visit.
Inclusion Criteria assessed at Visit 2 (Week 0) based on the 3-day micturition diary:
Exclusion Criteria:
Female participant who is lactating or is intending to breastfeed during the study period and for 30 days after the final study visit.
The participant has clinically significant bladder outlet obstruction (BOO) posing a risk of urinary retention.
Participant has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor.
Participant has evidence of Urinary Tract Infection (UTI) (urine culture greater than 100,000 cfu/mL) as assessed at Screening (Visit 1). The participant can be rescreened after successful treatment of the UTI (confirmed by a laboratory result of negative urine culture).
Participant has a neurological cause for detrusor overactivity (e.g., neurogenic bladder, diabetic neuropathy or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease).
Participant has an indwelling catheter or practices intermittent self-catheterization.
Participant has a chronic inflammatory condition such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs (i.e., within the confines of the pelvis including the bladder and rectum in both sexes and the uterus, ovaries, and fallopian tubes in females); or of the lower gastrointestinal tract.
Participant has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe colitis ulcerosa, toxic megacolon, myasthenia gravis, polio or any other medical condition which makes the use of anticholinergics contraindicated.
Participant has received intravesical injection in the past 12 months with botulinum toxin, resiniferatoxin, or capsaicin.
Participant has received invasive treatment including electro-stimulation therapy.
Participant is receiving a bladder training program or pelvic floor exercises which started or has changed less than 30 days prior to Screening.
Participant has hepatic impairment defined as Child-Pugh Class A, B or C.
Participant has severe renal impairment defined as creatinine clearance less than 30 mL/min. A participant with End Stage Renal Disease or undergoing dialysis is also not a candidate for the study.
Participant has severe uncontrolled hypertension, which is defined as a sitting systolic blood pressure greater than or equal 180 mmHg and/or diastolic blood pressure greater than or equal 110 mmHg.
Participant has evidence of QT prolongation on electrocardiogram (ECG) defined as QTcF greater than 450 msec for males, QTcF greater than 470 msec for females or a known history of QT prolongation.
Participant has a serum creatinine greater than 150 µmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2x upper limit of normal (ULN), or γ-GT greater than 3x ULN and considered clinically significant.
Participant has a hypersensitivity to any components of Myrbetriq (mirabegron), other β-AR agonists, tolterodine or other antimuscarinic agents, or any of the inactive ingredients.
Participant has been treated with an experimental device within 30 days or received an investigational agent within 30 days prior to Screening.
Participant has a concurrent malignancy or history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
Participant with current history of alcohol and/or drug abuse.
Participant is involved in the conduct of the study as an employee of the Astellas group, third party associated with the study, or the study site team.
Exclusion Criteria assessed at Visit 2 (Week 0):
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Scientific & Medical Affairs, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US10002 Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| Site US10004 Alaska Clinical Research Center, LLC |
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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After screening, participants were randomized into 1 of 4 sequences in a 5:5:1:1 ratio (mirabegron/tolterodine extended release (ER), tolterodine ER/mirabegron, mirabegron/mirabegron or tolterodine ER/tolterodine ER. Each participant completed 2 double-blind treatment periods with a 2-week washout period between the two periods.
Recruited participants were male and female over 18 years of age with overactive bladder (OAB) symptoms and naïve to pharmacologic treatment. The study was conducted at 36 sites (8 sites in Canada and 28 sites in the US).
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| ID | Title | Description |
|---|---|---|
| FG000 | AB: Mirabegron/Tolterodine ER | In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2. |
|
| Tolterodine ER | Drug | Oral |
|
|
| Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. | Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control | OAB control was scored from 0 to 100, with higher scores indicating better OAB control. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control | Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations | The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB | Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication | Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication | Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication | Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
| Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours | Baseline and EOT (Period 1-Week 8 and Period 2- Week 18) |
| Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours | Baseline and EOT (Period 1-Week 8 and Period 2- Week 18) |
| Number of Participants With Adverse Events | Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug. | Baseline to EOT (Week 18) and follow up (Week 20) |
| Anchorage |
| Alaska |
| 99503 |
| United States |
| Site US10001 Urological Associates of Southern Arizona | Tucson | Arizona | 85715 | United States |
| Site US10003 Genesis Research | San Diego | California | 92123 | United States |
| Site US10010 Skyline Urology | Sherman Oaks | California | 91411 | United States |
| Site US10028 Clinical Research Consulting | Milford | Connecticut | 06460 | United States |
| Site US10024 Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | United States |
| Site US10033 Eastern Research | Hialeah | Florida | 33013 | United States |
| Site US10023 Advanced Clinical Research of Miami | Miami | Florida | 33155 | United States |
| Site US10007 Pinellas Urology, Inc | St. Petersburg | Florida | 33710 | United States |
| Site US10022 Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Site US10008 The Iowa Clinic PC, Urology | West Des Moines | Iowa | 50266 | United States |
| Site US10014 Mid Atlantic Clinical Research | Greenbelt | Maryland | 20770 | United States |
| Site US10005 Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Site US10021 AccuMed Research Associates | Garden City | New York | 11530-1664 | United States |
| Site US10013 Advanced Urology Centers of New York | Plainview | New York | 11803 | United States |
| Site US10020 Upstate Clinical Research Associates LLC | Williamsville | New York | 14221 | United States |
| Site US10017 The Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Site US10057 Practice Research Organization | Dallas | Texas | 75230 | United States |
| Site US10035 Millennium Clinical Research Center | Arlington | Virginia | 22203 | United States |
| Site US10032 Clinical Research and Consulting Center, LLC | Fairfax | Virginia | 22030 | United States |
| Site US10034 Health Research of Hampton Roads Inc | Newport News | Virginia | 23606 | United States |
| Site CA15012 Glover Medical Clinic | Langley | British Columbia | V3A 4H9 | Canada |
| Site CA15008 Silverado Research | Victoria | British Columbia | V8T 2C1 | Canada |
| Site CA15003 The Male/Female Health & Research Centre | Barrie | Ontario | L4M 7G1 | Canada |
| Site CA15001 Jonathan Giddens Medicine Professional Corporation | Brampton | Ontario | L6T 4S5 | Canada |
| Site CA15011 Scisco Clinical Research | Cornwall | Ontario | K6H 4M4 | Canada |
| Site CA15002 RechercheGCP Research | Granby | Quebec | J2G 8Z9 | Canada |
| Site CA15007 RechercheGCP Research | Montreal | Quebec | H1M 1B1 | Canada |
| Site CA15005 CHUS - Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| FG001 | BA: Tolterodine ER /Mirabegron | In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. |
| FG002 | AA: Mirabegron/Mirabegron | In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period. |
| FG003 | BB: Tolterodine ER /Tolterodine ER | Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2. |
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| NOT COMPLETED |
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| Treatment Period 2 |
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The Randomized Analysis Set (RAS) included all participants who were randomized to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | AB: Mirabegron/Tolterodine ER | In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. |
| BG001 | BA: Tolterodine ER /Mirabegron | In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. |
| BG002 | AA: Mirabegron/Mirabegron | In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period. |
| BG003 | BB: Tolterodine ER /Tolterodine ER | Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Mean Number of Incontinence Episodes per 24 Hours | Mean | Standard Deviation | Incontinence Episodes/24 Hours |
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| Mean Number of Urgency Incontinence Episodes per 24 Hours | Mean | Standard Deviation | Urgency Incontinence Episodes |
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| Mean Number of Micturitions per 24 Hours | Mean | Standard Deviation | Micturitions |
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| Mean Number of Urgency Episodes per 24 Hours | Mean | Standard Deviation | Urgency Episodes |
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| Mean Number of Nocturia Episodes per 24 Hours | Number of participants with available data in treatment groups AB, BA, AA and BB are as follows; AB=138; BA=148; AA=29; BB=30. | Mean | Standard Deviation | Nocturia Episodes |
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| Duration of OAB Symptoms (Months) | Mean | Standard Deviation | Months |
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| Incontinence at Baseline of Period 1 | Wet: at least 1 incontinence episode at baseline of period 1. Dry: 0 incontinence episodes at baseline of period 1. | Number | Participants |
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| Type of OAB | Number | Participants |
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| Previous Nondrug Treatment for OAB | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT) | The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects). | The Full Analysis Set (FAS) comprised of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods. | Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 ("strong preference for period 1," "mild preference for period 1," "no preference," "mild preference for period 2," "strong preference for period 2"). Participants who selected either a "mild preference" or "strong preference" were considered as having a preference for a specific study drug and participants who selected "no preference" were considered as having no preference for one study drug over the other study drug." | Full Analysis Set (FAS-PNP [Preference/No Preference]) consisted of all randomized participant who took at least 14 days of double-blind study drug in each treatment period and had filled out the patient preference form. | Posted | Number | Percentage of participants | Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB. | Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control | OAB control was scored from 0 to 100, with higher scores indicating better OAB control. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control | Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations | The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB | Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Unit on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication | Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication | Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication | Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication. | Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Mean | Standard Error | Units on a Scale | Week 8 (End of Period 1) and Week 18 (End of Period 2) |
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| Secondary | Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours | Full Analysis Set Incontinence (FAS I) consisted of all participants in the FAS who had at least 1 incontinence episode in the baseline 3-day micturition diary and at least 1 postbaseline diary during period 1.Last observation carried forward imputation (LOCF) was utilized. | Posted | Least Squares Mean | Standard Error | Incontinence Episodes | Baseline and EOT (Period 1-Week 8 and Period 2- Week 18) |
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| Secondary | Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours | Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized. | Posted | Least Squares Mean | Standard Error | Micturitions | Baseline and EOT (Period 1-Week 8 and Period 2- Week 18) |
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| Secondary | Number of Participants With Adverse Events | Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug. | Safety Analysis Set consisted of all participants who received at least 1 dose of double-blind study drug (SAF). | Posted | Number | Participants | Baseline to EOT (Week 18) and follow up (Week 20) |
|
Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Treatment-emergent adverse events are defined as any adverse event starting or worsening in the period from first dose double-blind study drug until 15 days after last dose of double-blind study drug. If a participant reported TEAE for the same treatment in two different periods (sequences AA/BB), then that participant was counted once.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirabegron | Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period. | 3 | 319 | 55 | 319 | ||
| EG001 | Tolterodine ER | Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2. | 8 | 325 | 79 | 325 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA v16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v16.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA v16.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA v16.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA v16.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v16.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v16.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.0 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA v16.0 | Systematic Assessment | If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once. |
|
| Constipation | Gastrointestinal disorders | MedDRA v16.0 | Systematic Assessment | If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once. |
|
| Headache | Nervous system disorders | MedDRA v16.0 | Systematic Assessment | If a patient reported a TEAE for the same treatment in 2 different periods, then that patient was counted once. |
|
Institute and/or Principal Investigator may publish trial data generated at their specific study site after primary publication of the multi-site data. Sponsor must receive a site's manuscript at least 45 days prior to planned submission to ensure that no confidential information of Sponsor is included in the document. In addition if requested by sponsor any publication or presentation shall be delayed for a period not to exceed 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure | Astellas Pharma US, Inc. | Astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
Not provided
Not provided
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other - Miscellaneous |
|
| >= 65 Years |
|
| Male |
|
| Dry |
|
| Mixed |
|
| Frequency urgency without incontinence |
|
| No |
|
| OG001 |
| BA: Tolterodine ER /Mirabegron |
In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period. |
| OG002 | AA: Mirabegron/Mirabegron | In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period. |
| OG003 | BB: Tolterodine ER /Tolterodine ER | Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2. |
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