Study to Test the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00689104

Purpose

The study is intended to test efficacy, safety and tolerability of two doses of YM178 against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: YM178 Drug: Tolterodine 4 mg Drug: Placebo	Phase III

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multi-Center Study to Assess the Efficacy and Safety of the Beta-3 Agonist YM178 in Subjects With Symptoms of Overactive Bladder

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change from baseline to end of treatment in mean number of micturitions/24 h. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to end of treatment in mean number of incontinence episodes/24 h. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean volume voided per micturition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in mean number of urgency incontinence episodes/24 h. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in mean number of urgency episodes (grade 3 and/or 4) /24 h. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	2160
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental low dose	Drug: YM178 Oral
2: Experimental higher dose	Drug: YM178 Oral
3: Active Comparator	Drug: Tolterodine 4 mg Oral
4: Placebo Comparator	Drug: Placebo Oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is willing and able to complete the micturition diary and questionnaires correctly
Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
Subject 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:

Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
Subject has an indwelling catheter or practices intermittent self-catheterization
Subject has diabetic neuropathy
Subject has 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
Subject receives non-drug treatment including electro-stimulation therapy
Subject has severe hypertension
Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other ß-AR agonists, or lactose or any of the other inactive ingredients
Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
Subject has serum creatinine >150 umol/L, AST and/or ALT > 2x upper limit of normal range (ULN), or γ-GT > 3x ULN
Subject has a clinically significant abnormal ECG

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689104

Contacts

Contact: Medical Clinical Developmental Department

31-71-54-5745

Show 220 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Europe BV

More Information

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	178-CL-046, EudraCT number 2007-001451-19
Study First Received:	May 29, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00689104
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Office for Safety in Health Care; Belarus: Ministry of Health; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; Iceland: Icelandic Medicines Control Agency; Ireland: Irish Medicines Board; Italy: Ethics Committee; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:

Overactive bladder (OAB)
Frequency
Micturition
Urgency

Urinary incontinence
Urinary urge incontinence
YM178

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Urinary Bladder Diseases
Urinary Incontinence
Urinary Incontinence, Urge
Tolterodine

Additional relevant MeSH terms:

Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009