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Study to Test the Efficacy and Safety of YM178 in Subjects With Symptoms of Overactive Bladder

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: YM178 (Drug); tolterodine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Astellas Pharma Europe B.V.

Official(s) and/or principal investigator(s):
Clinical Study Manager, Study Director, Affiliation: Astellas Pharma Europe B.V.

Summary

The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and tolterodine to treat patients with symptoms of over active bladder.

Clinical Details

Official title: A Randomized, Double-blind, Parallel Group, Proof of Concept Study of YM178 in Comparison With Placebo and Tolterodine in Patients With Symptomatic Overactive Bladder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in mean number of micturitions per 24 hours

Secondary outcome:

Change from baseline in mean number of urgency episodes/24 hours

Change from baseline in mean volume voided per micturition

Change from baseline in mean number of urge incontinence episodes/24 hours

Change from baseline in mean number of incontinence episodes/24 hours

Detailed description: This is a multinational, multicenter, double-blind, double-dummy, randomized, parallel group, placebo and active controlled phase II proof-of concept study. Patients are enrolled into a single-blind, 2-week placebo run in period after which they are randomized to 4 weeks of double-blind treatment with YM178 (low dose and high dose), placebo or tolterodine. Subsequently patients will be followed for an additional 2 weeks with single-blind placebo treatment. There are 6 visits in total: visit 1 at enrolment, visit 2 (baseline) after the 2-week placebo run-in, visits 3, 4 and 5 after 1, 2 and 4 weeks of double-blind treatment respectively, and visit 6 after a 2-week follow-up.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is willing and able to complete the micturition diary correctly.

- Symptoms of overactive bladder (urinary frequency and urgency with or without

incontinence) for ≥ 3 months At randomization:

- Patient must experience frequency of micturition on average ≥ 8 times per 24-hour

period during the 3-day micturition diary period

- Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without

incontinence, during the 3-day micturition diary period Exclusion Criteria:

- Pregnant women or women who intend to become pregnant during the study or women of

childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants, contraceptive patches and injectable contraceptives

- Clinically significant outflow obstruction (at the discretion of the investigator)

- Significant post void residual volume (PVR>200ml)

- Significant stress incontinence or mixed stress/urge incontinence where stress is the

predominant factor as determined by the investigator (for female patients confirmed by a cough provocation test)

- Patients with a neurological cause for abnormal detrusor activity

- Diabetic neuropathy

- Evidence of a symptomatic urinary tract infection, chronic inflammation such as

interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

- Uncontrolled narrow angle glaucoma, urinary or gastric retention, colitis ulcerosa,

toxic megacolon, myasthenia gravis or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated

- Non-drug treatment including electrostimulation therapy (a bladder training program

or pelvic floor exercises which started more than 1 month prior to entry into the study can be continued)

- Use of medications intended to treat urinary incontinence or listed in Appendix 1

Part A. Part B lists medications that are restricted but accepted under certain conditions

- Known or suspected hypersensitivity to tolterodine, other anticholinergics,

ß-adrenoceptor agonists, or lactose or any of the other inactive ingredients

- Any clinically significant cardiovascular complication including CVA, recent

myocardial infarction and uncontrolled hypertension, indicated by a sitting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg

- Any clinically significant condition, which in the opinion of the investigator makes

the patient unsuitable for the trial

- Participation in any clinical trial within 30 (90 in the UK) days prior to

randomization

- Employees of the sponsor, third parties associated with the study, or the study site

At randomization:

- Patient who did not complete the micturition diary according to the instructions

- Average total daily urine volume > 3000 ml as recorded in the micturition diary

- Clinically significant elevation of serum creatinine or liver enzymes as evidenced by

creatinine >150 mmol/L, ASAT or ALAT > 2x upper limit of normal range (ULN), γ-GT > 3x ULN and/or abnormal serum total bilirubin (as assessed in visit 1 samples or alternative sampling within 4 weeks prior to visit 1)

Locations and Contacts

Site: 12, Brussels 1090, Belgium

Site: 13, Edegem 2650, Belgium

Site: 11, Gent 9000, Belgium

Site: 10, Leuven 3000, Belgium

Site: 25, Melnik 276 01, Czech Republic

Site: 20, Prague 180 81, Czech Republic

Site: 22, Prague 128 08, Czech Republic

Site: 24, Prague 140 59, Czech Republic

Site: 21, Usti nad Labem 40001, Czech Republic

Site: 23, Usti nad Labem 401 13, Czech Republic

Site: 32, Bad Ems 56130, Germany

Site: 30, Emmendingen 79312, Germany

Site: 35, Frankfurt 60326, Germany

Site: 34, Hagenow 19230, Germany

Site: 33, Hamburg 20253, Germany

Site: 36, Koblenz 56068, Germany

Site: 31, Trier 54290, Germany

Site: 42, Alzira-Valencia 46600, Spain

Site: 40, Madrid 28046, Spain

Site: 43, Miranda de Ebro 09200, Spain

Site: 55, Gotenburg 413 45, Sweden

Site: 53, Linkoping 582 24, Sweden

Site: 50, Lund 221 85, Sweden

Site: 51, Stockholm 141 86, Sweden

Site: 52, Uppsala 751 85, Sweden

Site: 64, Bimingham B15 2TG, United Kingdom

Site: 62, London N19 5LW, United Kingdom

Site: 63, London W1P 7PN, United Kingdom

Site: 60, Sheffield S10 2JF, United Kingdom

Site: 61, Swansea SA6 6NL, United Kingdom

Additional Information

Link to Results on JAPIC

Starting date: April 2004
Last updated: July 1, 2013

Page last updated: August 23, 2015

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