Phase 3
Completed N=1,306
A Study to Test the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT00912964 ↗
Enrolled (actual)
1,306
Serious AEs
1.8%
Results posted
Oct 2012
Primary outcomePrimary: Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours — -0.96; -1.36; -1.38 Incontinence episodes — p=0.005
Summary
The study is intended to test efficacy, safety and tolerability of two doses of once daily (qd) Mirabegron against placebo to treat patients with symptoms of overactive bladder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours |
-0.96; -1.36; -1.38 | 0.005 sig |
| PRIMARY Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours |
-1.18; -1.65; -1.60 | 0.007 sig |
| SECONDARY Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition |
8.3; 12.8; 20.7 | 0.15 |
| SECONDARY Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours |
-0.62; -0.96; -1.13 | 0.039 sig |
| SECONDARY Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours |
-0.78; -0.96; -1.14 | 0.30 |
| SECONDARY Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency |
-0.15; -0.22; -0.29 | 0.083 |
| SECONDARY Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
-0.95; -1.31; -1.33 | 0.004 sig |
| SECONDARY Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours |
-1.35; -1.68; -1.94 | 0.13 |
| SECONDARY Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours |
-1.09; -1.52; -1.53; -1.47; -1.68; -1.69 | — |
| SECONDARY Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours |
-1.04; -1.38; -1.39; -1.08; -1.36; -1.43 | — |
| SECONDARY Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition |
7.6; 10.6; 17.8; 9.8; 15.7; 17.9 | — |
| SECONDARY Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours |
-0.63; -0.98; -1.12; -1.02; -1.33; -1.39 | — |
| SECONDARY Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours |
-0.90; -0.97; -1.47; -1.17; -1.51; -1.73 | — |
| SECONDARY Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency |
-0.10; -0.12; -0.20; -0.15; -0.19; -0.26 | — |
| SECONDARY Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours |
-0.30; -0.27; 0.38; -0.45; -0.41; -0.44 | — |
| SECONDARY Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours |
-0.72; -0.59; -0.81; -0.97; -0.79; -1.16 | — |
| SECONDARY Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
28.2; 31.5; 36.5; 41.9; 44.7; 41.9 | — |
| SECONDARY Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit |
46.6; 54.7; 61.6; 62.7; 71.7; 71.4 | — |
| SECONDARY Percentage of Responders for Mean Level of Urgency |
36.6; 40.5; 44.8 | — |
| SECONDARY Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes |
44.6; 47.1; 57.7 | — |
| SECONDARY Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score |
-12.2; -13.7; -12.7; -15.1; -17.4; -18.5 | — |
| SECONDARY Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score |
8.8; 11.4; 9.2; 12.1; 14.3; 13.8 | — |
| SECONDARY Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed |
0.6; 0.7; -1.5; 0.6; 0.7; -1.3 | — |
| SECONDARY Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working |
-11.6; -10.2; -13.0; -11.5; -10.1; -13.1 | — |
| SECONDARY Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment |
-14.1; -11.0; -13.3; -13.8; -10.8; -13.3 | — |
| SECONDARY Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment |
-11.4; -12.3; -13.1; -11.0; -11.9; -13.3 | — |
| SECONDARY Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score |
327; 310; 304; 16; 20; 33 | — |
| SECONDARY Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score |
389; 385; 403; 5; 10; 6 | — |
| SECONDARY Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score |
313; 303; 293; 27; 27; 31 | — |
| SECONDARY Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score |
209; 200; 185; 34; 36; 41 | — |
| SECONDARY Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score |
239; 243; 225; 20; 29; 33 | — |
| SECONDARY Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) |
0.38; 2.43; 1.67; 3.14; 3.95; 4.13 | — |
| SECONDARY Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC) |
-0.7; -0.8; -0.8; -0.7; -0.8; -0.7 | — |
| SECONDARY Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS) |
1.18; 1.58; 1.94; 1.05; 1.54; 1.88 | — |
| SECONDARY Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician |
0.0; -0.0; -0.0; -0.0; -0.0; 0.0 | — |
| SECONDARY Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale |
182; 188; 196; 0; 2; 0 | — |
| SECONDARY Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale |
188; 194; 202; 4; 4; 2 | — |
| SECONDARY Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale |
188; 194; 202; 3; 5; 2 | — |
| SECONDARY Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit |
56.0; 52.8; 55.8; 55.1; 52.7; 55.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is willing and able to complete the micturition diary and questionnaires correctly
- Patient has symptoms of overactive bladder (OAB) for ≥ 3 months
- Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
- Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period
Exclusion Criteria
- Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
- Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Patient is using medications intended to treat OAB
- Patient has an indwelling catheter or practices intermittent self-catheterization
- Patient has diabetic neuropathy
- Patient has evidence of urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- Patient receives non-drug treatment including electro-stimulation therapy
- Patient has severe hypertension
- Patient has participated in a clinical study within 30 days, or had participated in any previous study with mirabegron
- Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
- Patient has serum creatinine of >150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or gamma-glutamyl transpeptidase (γ-GT) > 3x ULN
- Patient has a clinically significant abnormal electrocardiogram (ECG)
Data sourced from ClinicalTrials.gov (NCT00912964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.