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A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin) (BESIDE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01908829
First received: July 24, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) will be more effective in controlling incontinence than when using the antimuscarinc treatment alone.


Condition Intervention Phase
Urinary Bladder Overactive
Urinary Bladder Diseases
Urologic Diseases
Drug: Mirabegron
Drug: Solifenacin succinate low dose
Drug: Solifenacin succinate high dose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from Baseline in mean number of incontinence episodes per 24 hours [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean number of micturitions per 24 hours [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Number of incontinence episodes reported over 3-day diary [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean volume voided per micturition [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency incontinence episodes per 24 hours [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Number of urgency incontinence episodes reported over 3-day diary [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency episodes (grade 3 or 4) per 24 hours [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of pads per 24 hours [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Number of pads reported over 3-day diary [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of nocturia Episodes reported in 3-day diary [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Number of nocturia episodes reported over 3-day diary [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with zero incontinence episodes per 24 hrs at End of Treatment [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with a mean of less than 8 micturitions per 24 hours at End of Treatment [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in total Euroqol European Quality of Life-5 Dimensions (EQ-5D) score (and subscale scores) [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in total OAB-q score (and subscale scores) [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of responders with at least a 10-point improvement from Baseline in OAB-q subscales [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) score [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in Patient Perception Bladder Control (PPBC) score [ Time Frame: Baseline to end of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with at least a 1-point improvement from baseline in PPBC [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with major (at least 2-point) improvement from baseline in PPBC [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]
  • Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) [ Time Frame: End of treatment (12 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 2172
Study Start Date: July 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination therapy
Solifenacin succinate low dose plus Mirabegron low dose (first 4 weeks) rising to Mirabegron high dose (for subsequent 8 weeks)
Drug: Mirabegron
Oral tablet
Other Names:
  • YM178,
  • Betanis,
  • Betmiga,
  • Myrbetriq
Active Comparator: Solifenacin succinate low dose Drug: Solifenacin succinate low dose
Oral tablet
Other Names:
  • Vesicare,
  • Vesitrim,
  • Vesikur,
  • YM905
Active Comparator: Solifenacin succinate high dose Drug: Solifenacin succinate high dose
Oral tablet
Other Names:
  • Vesicare,
  • Vesitrim,
  • Vesikur,
  • YM905

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Main Inclusion at Screening:

    1. Subject has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for >= 3 months prior to the screening visit
    2. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;
    3. Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.
  • Main Inclusion at Run-in (Visit 2):

    1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.
    2. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.
    3. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.
  • Main Inclusion at Randomization (Visit 3):

    1. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.

Exclusion Criteria:

  • Main Exclusion at Screening:

    1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
    2. Subject has significant Post-voidal residual (PVR) volume (PVR > 150 ml).
    3. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
    4. Subject has an indwelling catheter or practices intermittent self catheterization.
    5. Subject has evidence of a UTI.
    6. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
    7. Subject has moderate to severe hepatic impairment
    8. Subject has severe renal impairment or End Stage Renal disease
    9. Subject has a clinically significant abnormal Electrocardiogram (ECG)
    10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
    11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
    12. Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
    13. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
  • Main Exclusion at Randomization (visit 3):

    1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence episodes are recorded in the 3 day diary administered for 3 days prior to Visit 3).
    2. Subject does not desire an increase in study medication.
    3. Subject has an average total daily urine volume > 3000ml as recorded in the micturition diary.
    4. Subject has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
    5. Subject has a clinically significant abnormal ECG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908829

Contacts
Contact: Medical Affairs Europe +44 (0)20 3379 8000 contact@nl.astellas.com

  Show 331 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Clinical Study Manager Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01908829     History of Changes
Other Study ID Numbers: 905-EC-012, 2012-005401-41
Study First Received: July 24, 2013
Last Updated: March 12, 2014
Health Authority: Algeria: Ministry of Health
Armenia: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health, Drug Policy and Planning Center
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Ministry of Health
Kazakhstan: Ministry of Public Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: The Central Register of Clinical Trials
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Overactive Bladder (OAB)
Urinary incontinence
Urgency incontinence
Frequency
Urgency
Micturition
YM178
Mirabegron
Solifenacin
Betmiga
Myrbetriq
Betanis
Vesicare
Vesitrim
Vesikur
YM905

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urologic Diseases
Urinary Bladder, Overactive
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014