A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients
This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01745094
First received: December 6, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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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 labo-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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 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:
Drug: solifenacin
oral
Other Names:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745094
Contacts
| Contact: Clinical Development Administration Dept. | clintrialtrials_info@jp.astellas.com |
Locations
| Japan | |
| Recruiting | |
| Chubu, Japan | |
| Recruiting | |
| Hokkaido, Japan | |
| Recruiting | |
| Kansai, Japan | |
| Recruiting | |
| Kantou, Japan | |
| Recruiting | |
| 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: | December 6, 2012 |
| 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 May 23, 2013