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

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00662909

Purpose

The study is intended to test the efficacy, safety and tolerability of two doses of YM178 against placebo to treat patients with symptoms of overactive bladder

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

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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change from baseline to end of treatment in mean number of micturitions per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline to end of treatment in mean number of incontinence episode per 24 hours [ 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 per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Change from baseline in mean number of urgency episodes (grade 3 and/or 4) per 24 hours [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment:	2190
Study Start Date:	April 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 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: 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 for >= 3 months
Subject must experience 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 YM178, other ß-AR agonists, or any of the other inactive ingredients
Subject has been treated with any investigational drug or device within 30 days
Subject had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
Subject has serum creatinine of >150 μmol/L, or AST 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: NCT00662909

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Locations

United States, Alabama

Montgomery, Alabama, United States, 36117

Huntsville, Alabama, United States, 35801

Homewood, Alabama, United States, 35209

Mobile, Alabama, United States, 36608
United States, Alaska

Anchorage, Alaska, United States, 99508
United States, Arizona

Phoenix, Arizona, United States, 85051

Tucson, Arizona, United States, 85741

Tucson, Arizona, United States, 85712
United States, California

San Diego, California, United States, 92108

Buena Park, California, United States, 90620

La Mesa, California, United States, 91942

Fresno, California, United States, 93720

Atherton, California, United States, 94027

Beverly Hills, California, United States, 90211

Newport Beach, California, United States, 92660

San Bernardino, California, United States, 92404

Tarzana, California, United States, 91356

Torrance, California, United States, 90505

Orange, California, United States, 92869

Los Angeles, California, United States, 90017

Burbank, California, United States, 91506

Sacramento, California, United States, 95816

Mission Hills, California, United States, 91345

San Francisco, California, United States, 94102

San Diego, California, United States, 92120

Carmichael, California, United States, 95608
United States, Colorado

Englewood, Colorado, United States, 80112

Denver, Colorado, United States, 80211

Aurora, Colorado, United States, 80012

Denver, Colorado, United States, 80218
United States, Connecticut

Waterbury, Connecticut, United States, 06708

New Britain, Connecticut, United States, 06052
United States, Florida

Sarasota, Florida, United States, 34237

Pembroke Pines, Florida, United States, 33027

Wellington, Florida, United States, 33414

Tallahassee, Florida, United States, 32308

Pembroke Pines, Florida, United States, 33024

Orlando, Florida, United States, 32803

West Palm Beach, Florida, United States, 33407

Clearwater, Florida, United States, 33761

Aventura, Florida, United States, 33180

Tampa, Florida, United States, 33606

Clearwater, Florida, United States, 33756

Fort Myers, Florida, United States, 33916

Ocala, Florida, United States, 34471

Celebration, Florida, United States, 34747
United States, Georgia

Roswell, Georgia, United States, 30076

Decatur, Georgia, United States, 30034

Atlanta, Georgia, United States, 30328

Atlanta, Georgia, United States, 30308

Alpharetta, Georgia, United States, 30005
United States, Idaho

Coeur d'Alene, Idaho, United States, 83814

Idaho Falls, Idaho, United States, 83404
United States, Illinois

Melrose Park, Illinois, United States, 60160
United States, Indiana

Newburgh, Indiana, United States, 47630

Jeffersonville, Indiana, United States, 47130

Fort Wayne, Indiana, United States, 46825
United States, Iowa

Des Moines, Iowa, United States, 50309
United States, Kansas

Wichita, Kansas, United States, 57207
United States, Louisiana

Shreveport, Louisiana, United States, 71106
United States, Maryland

Greenbelt, Maryland, United States, 20770
United States, Massachusetts

Watertown, Massachusetts, United States, 02472

Springfield, Massachusetts, United States, 01103
United States, Missouri

North Kansas City, Missouri, United States, 64116
United States, Montana

Billings, Montana, United States, 59102
United States, Nebraska

Omaha, Nebraska, United States, 68114

Lincoln, Nebraska, United States, 68516
United States, Nevada

Las Vegas, Nevada, United States, 89148
United States, New Jersey

West Orange, New Jersey, United States, 07052
United States, New Mexico

Albuquerque, New Mexico, United States, 87109
United States, New York

Kingston, New York, United States, 12401

Poughkeepsie, New York, United States, 12601

Garden City, New York, United States, 11530

Albany, New York, United States, 12208

Endwell, New York, United States, 13760
United States, North Carolina

Winston Salem, North Carolina, United States, 27103

Wilmington, North Carolina, United States, 28401

Concord, North Carolina, United States, 28025

Cary, North Carolina, United States, 27518

Charlotte, North Carolina, United States, 28209
United States, North Dakota

Fargo, North Dakota, United States, 58104
United States, Ohio

Cincinnati, Ohio, United States, 45212

Wadsworth, Ohio, United States, 44281

Columbus, Ohio, United States, 43214

Lyndhurst, Ohio, United States, 44124

Cleveland, Ohio, United States, 44122
United States, Oklahoma

Edmond, Oklahoma, United States, 73034

Bethany, Oklahoma, United States, 73008
United States, Pennsylvania

Reading, Pennsylvania, United States, 19611

Lancaster, Pennsylvania, United States, 17604

Bala Cynwyd, Pennsylvania, United States, 19004

Philadelphia, Pennsylvania, United States, 19114
United States, Rhode Island

Warwick, Rhode Island, United States, 02886
United States, South Carolina

Simpsonville, South Carolina, United States, 29681

Greer, South Carolina, United States, 29650

Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee

Bristol, Tennessee, United States, 37620
United States, Texas

Austin, Texas, United States, 78759

Dallas, Texas, United States, 75231

Houston, Texas, United States, 77024

Corpus Christi, Texas, United States, 78414

Arlington, Texas, United States, 76017

San Antonio, Texas, United States, 78229
United States, Utah

Salt Lake City, Utah, United States, 84107
United States, Virginia

Norfolk, Virginia, United States, 23502
United States, Washington

Spokane, Washington, United States, 99204

Mountlake Terrace, Washington, United States, 98043

Seattle, Washington, United States, 98166

Tacoma, Washington, United States, 98405
Canada, British Columbia

Victoria, British Columbia, Canada, V8T 5G1

Surrey, British Columbia, Canada, V3V 1N1
Canada, New Brunswick

St Johns, New Brunswick, Canada, E2L 3J8
Canada, Ontario

Kitchener, Ontario, Canada, N2N 2B9

Barrie, Ontario, Canada, L4M 7G1

North Bay, Ontario, Canada, P1B 7K8

Toronto, Ontario, Canada, M5T 2S8

Brampton, Ontario, Canada, L6T 4S5

Toronto, Ontario, Canada, M4N 3M5

Newmarket, Ontario, Canada, L3X 1W1

Thunder Bay, Ontario, Canada, P7E 6E7

Oshawa, Ontario, Canada, L1H 1B9

Toronto, Ontario, Canada, M6S 4W4

Owen Sound, Ontario, Canada, M4K 2J1
Canada, Quebec

Pointe-Claire, Quebec, Canada, H9R 4S3

Granby, Quebec, Canada, J2G 8Z9

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma Global Development

Responsible Party:	Astellas Pharma Global Development ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	178-CL-047
Study First Received:	April 17, 2008
Last Updated:	May 20, 2009
ClinicalTrials.gov Identifier:	NCT00662909 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada