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

Urinary Bladder, Overactive Clinical Trial

— Blossom  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604928
• Other study ID #: 178-CL-008
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2012
• Last updated: February 14, 2017
• Start date: April 2004
• Est. completion date: January 2005

Study information

• Verified date: February 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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), ?-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)

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• YM178
Oral
• tolterodine
Oral
• Placebo
Oral

Locations

Country	Name	City	State
Belgium	Site: 12	Brussels
Belgium	Site: 13	Edegem
Belgium	Site: 11	Gent
Belgium	Site: 10	Leuven
Czech Republic	Site: 25	Melnik
Czech Republic	Site: 20	Prague
Czech Republic	Site: 22	Prague
Czech Republic	Site: 24	Prague
Czech Republic	Site: 21	Usti nad Labem
Czech Republic	Site: 23	Usti nad Labem
Germany	Site: 32	Bad Ems
Germany	Site: 30	Emmendingen
Germany	Site: 35	Frankfurt
Germany	Site: 34	Hagenow
Germany	Site: 33	Hamburg
Germany	Site: 36	Koblenz
Germany	Site: 31	Trier
Spain	Site: 42	Alzira-Valencia
Spain	Site: 40	Madrid
Spain	Site: 43	Miranda de Ebro
Sweden	Site: 55	Gotenburg
Sweden	Site: 53	Linkoping
Sweden	Site: 50	Lund
Sweden	Site: 51	Stockholm
Sweden	Site: 52	Uppsala
United Kingdom	Site: 64	Bimingham
United Kingdom	Site: 62	London
United Kingdom	Site: 63	London
United Kingdom	Site: 60	Sheffield
United Kingdom	Site: 61	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of micturitions per 24 hours		Baseline and 4 weeks (end of treatment)
Secondary	Change from baseline in mean number of urgency episodes/24 hours		Baseline and 4 weeks (end of treatment)
Secondary	Change from baseline in mean volume voided per micturition		Baseline and 4 weeks (end of treatment)
Secondary	Change from baseline in mean number of urge incontinence episodes/24 hours		Baseline and 4 weeks (end of treatment)
Secondary	Change from baseline in mean number of incontinence episodes/24 hours		Baseline and 4 weeks (end of treatment)

External Links

•   Link to results on Astellas Clinical Study Results website