Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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17 August 2015 |
Main ID: |
EUCTR2012-005401-41-BE |
Date of registration:
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18/06/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A trial comparing combination treatment (solifenacin plus mirabegron) with one treatment alone (solifenacin).
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Scientific title:
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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. - BESIDE |
Date of first enrolment:
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27/08/2013 |
Target sample size:
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2170 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005401-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3
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Phase:
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Countries of recruitment
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Algeria
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Armenia
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Australia
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Austria
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Belgium
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Canada
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Denmark
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Egypt
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Finland
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Georgia
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Greece
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Hungary
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Ireland
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Israel
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Jordan
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Kazakhstan
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Korea, Republic of
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Lebanon
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Netherlands
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New Zealand
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Norway
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Poland
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Portugal
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Russian Federation
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Slovakia
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Slovenia
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Spain
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Sweden
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Taiwan
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Service Desk
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Address:
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Sylviusweg 62
2333 BE
Leiden
Netherlands |
Telephone:
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00310715455878 |
Email:
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contact@nl.astellas.com |
Affiliation:
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Global Development Operations |
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Name:
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Service Desk
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Address:
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Sylviusweg 62
2333 BE
Leiden
Netherlands |
Telephone:
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00310715455878 |
Email:
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contact@nl.astellas.com |
Affiliation:
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Global Development Operations |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subject has symptoms of OAB (urinary frequency [an average of at least 8 episodes per day] 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1410 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 760
Exclusion criteria: 1. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
2. Subject has significant 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
9. Subject has a clinically significant abnormal 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Body processes [G] - Physical Phenomena [G01]
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Overactive Bladder MedDRA version: 17.1
Level: LLT
Classification code 10059617
Term: Overactive bladder
System Organ Class: 100000004857
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Intervention(s)
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Trade Name: Betmiga Product Name: mirabegron Product Code: YM178 Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: mirabegron CAS Number: 223673-61-8 Current Sponsor code: YM178 Other descriptive name: MIRABEGRON Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use
Trade Name: Betmiga Product Name: mirabegron Product Code: YM178 Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: mirabegron CAS Number: 223673-61-8 Current Sponsor code: YM178 Other descriptive name: MIRABEGRON Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use
Trade Name: Vesicare Product Name: solifenacin succinate Pharmaceutical Form: Film-coated tablet INN or Proposed INN: solifenacin succinate CAS Number: 242478-38-2 Current Sponsor code: YM905 Other descriptive name: SOLIFENACIN SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Vesicare Product Name: solifenacin succinate Pharmaceutical Form: Film-coated tablet INN or Proposed INN: solifenacin succinate CAS Number: 242478-38-2 Current Sponsor code: YM905 Other descriptive name: SOLIFENACIN SUCCINATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: - To evaluate the safety and tolerability of combination therapy versus solifenacin 5mg and solifenacin 10mg monotherapy - To evaluate the efficacy of combination therapy versus solifenacin 10mg monotherapy
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Timepoint(s) of evaluation of this end point: Baseline visit (Visit 3/Randomization) to End of Treatment (Visit 6).
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Primary end point(s): Change from Baseline in mean number of incontinence episodes
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Main Objective: To evaluate the efficacy of solifenacin 5 mg plus mirabegron 50 mg versus solifenacin 5 mg monotherapy
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Baseline Visit (Visit 3/Randomization) to end of Treatment (Visit 6).
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Secondary end point(s): Change from Baseline in mean number of micturitions per 24 hours
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Secondary ID(s)
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905-EC-012
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2012-005401-41-SK
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Source(s) of Monetary Support
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Astellas Pharma Europe Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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