A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01745094
First received: December 6, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of concomitant use of mirabegron in patients with overactive bladder under treatment with solifenacin.


Condition Intervention Phase
Overactive Bladder
Drug: mirabegron
Drug: solifenacin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Marketing Clinical Study of Mirabegron -Add-on Therapy With Mirabegron in Patients With Overactive Bladder Under Treatment With Solifenacin-

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety assessed by the incidence of adverse events, vial signs lab tests, 12-lead ECGs, QTc-intervals Urine volume and uroflowmetry [ Time Frame: for 16 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in OABSS (OverActive Bladder Symptom Score) [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in OAB-q (OverActive Bladder questionnaire) short form (QAB-q SF) score [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of micturition episodes per 24 hour [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urinary incontinence episodes per 24 hours [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
  • Change from baseline in mean volume voided per micturition [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant Group
concomitant administration of mirabegron to solifenacin treated patients
Drug: mirabegron
oral
Other Names:
  • YM178
  • Betanis
Drug: solifenacin
oral
Other Names:
  • YM905
  • Vesicare

Detailed Description:

The duration of the study will be a total of 18 weeks including a 2-week screening period and 16 week treatment period. At week 8 visit, the dose of mirabegron can be increased based on agreement of the subject if mirabegron, in the opinion of the investigator or sub-investigator, is not fully effective.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female: postmenopausal OAB outpatient
  • Male: OAB outpatient who has no wish to have children in the future
  • Patient has been under treatment with solifenacin at a stable dose once daily for at least 4 weeks prior to the study
  • Patient has a total OABSS score of ≥3 points and a Question 3 score ≥2 points

Exclusion Criteria:

  • Patient has a residual urine volume of ≥100 mL or a maximum flow rate <5 mL/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction
  • Patient has serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient has malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence)
  • Patient has received surgical therapy that may affect the urinary tract function within 24 wk before the start of the screening period
  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: NCT01745094

Locations
Japan
Chubu, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01745094     History of Changes
Other Study ID Numbers: 178-CL-110
Study First Received: December 6, 2012
Last Updated: June 24, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
solifenacin
mirabegron

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
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 23, 2014