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临床试验/NCT02045862
NCT02045862已完成3 期

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder

Astellas Pharma Europe B.V.251 个研究点 分布在 1 个国家目标入组 1,829 人开始时间: 2014年3月17日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,829
试验地点
251
主要终点
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Main Inclusion at Screening (Visit 1):
  • •Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months);
  • •Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
  • •Main Inclusion at Randomization (Visit 2):
  • •Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition).
  • •Subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period.
  • •Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day micturition diary period.

排除标准

  • •Main Exclusion at Screening (Visit 1):
  • •Subject had clinically significant bladder outflow obstruction at risk of urinary retention;
  • •Subject had significant PVR volume (> 150 mL);
  • •Subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor;
  • •Subject has an indwelling catheter or practices intermittent self-catheterization;
  • •Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
  • •Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin;
  • •Main Exclusion at Randomization (Visit 2):
  • •Subject had evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite).
  • •Subject had an average total daily urine volume > 3000 mL as recorded in the micturition diary period.

研究组 & 干预措施

Solifenacin 5 mg + Mirabegron 50 mg

Experimental

Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.

干预措施: Solifenacin succinate (Drug)

Solifenacin 5 mg

Active Comparator

Participants received solifenacin 5 mg once a day for 52 weeks.

干预措施: Solifenacin succinate (Drug)

Solifenacin 5 mg + Mirabegron 50 mg

Experimental

Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.

干预措施: Mirabegron (Drug)

Solifenacin 5 mg

Active Comparator

Participants received solifenacin 5 mg once a day for 52 weeks.

干预措施: Placebo to match mirabegron (Drug)

Mirabegron 50 mg

Active Comparator

Participants received mirabegron 50 mg once a day for 52 weeks.

干预措施: Placebo to match solifenacin (Drug)

Mirabegron 50 mg

Active Comparator

Participants received mirabegron 50 mg once a day for 52 weeks.

干预措施: Mirabegron (Drug)

结局指标

主要结局

Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

时间窗: Baseline and Week 52

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 from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.

Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours

时间窗: Baseline and Week 52

A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

时间窗: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)

A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).

次要结局

  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping(Baseline and Months 1, 3, 6, 9, 12)
  • Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit(Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours(Baseline and Months 1, 3, 6, 9, 12)
  • Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)(Months 1, 3, 6, 9, 12)
  • Change From Baseline to EoT in Corrected Micturition Frequency(Baseline and Month 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours(Baseline and Months 1, 3, 6, 9, 12)
  • Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities(Baseline and Month 12)
  • Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression(Baseline and Month 12)
  • Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed(Baseline and Months 6,12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit(Baseline and Months 1, 3, 6, 9, 12)
  • Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort(Baseline and Month 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and Months 1, 3, 6, 9, 12)
  • Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit(Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT(Month 12)
  • Change From Baseline to EoT in Mean Volume Voided Per Micturition(Baseline and Week 52)
  • Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)(Baseline and Week 52)
  • Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score(Baseline and Week 52)
  • Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit(Months 1, 3, 6, 9, 12)
  • Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit(Months 1, 3, 6, 9, 12)
  • Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit(Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition(Baseline and Months 3, 6, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours(Baseline and Months 1, 3, 6, 9, 12)
  • Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit(Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT(Month 12)
  • Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility(Baseline and 12 Months)
  • Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care(Baseline and Month 12)
  • Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working(Baseline and Months 6, 12)
  • Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT(Months 1, 3, 6, 9, 12)
  • Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment(Baseline and Months 6, 12)
  • Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment(Baseline and Months 6, 12)
  • Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)
  • Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT(Months 1, 3, 6, 9, 12)
  • Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT(Baseline and Months 1, 3, 6, 9, 12)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (251)

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