Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

Overactive Bladder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868516
• Other study ID #: TC-5214-23-CRD-003
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2013
• Last updated: May 11, 2015
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Targacept Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.

Description:

The study included a three- or five-week screening period, followed by a 12-week treatment period during which patients received either one of three doses of dexmecamylamine or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period. A total of 768 subjects with overactive bladder were randomized into the double-blind treatment period of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1635
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Verified medical history of overactive bladder for at least 6 months

• Capable of walking unassisted to use the bathroom

• Able to measure voided urine volume and complete the diary without assistance

• If the subject is currently being treated with an OAB medication, the subject is willing to discontinue OAB medications while participating in this study

Exclusion Criteria:

• Diagnosis of a neurological disease affecting bladder function

• Stress incontinence, insensate incontinence, overflow incontinence or incontinence due to urinary fistula

• History of incomplete bladder emptying, bladder outflow obstruction or post-void residual bladder volume > 150 mL

• Males with benign prostatic hyperplasia or with a prostate-specific antigen (PSA) of 4 ng/mL or more

• Other urinary tract pathology such as malignancy, ureteric reflux, bladder stone, uninvestigated hematuria, urethral stricture, or cystitis

• Prior treatment with intravesical or intraprostatic botulinum toxin in the last 2 years

• Myasthenia gravis

• Angle closure glaucoma

• Current implantation of interstim electrodes or vaginal surgical mesh

• Presence of a clinically significant medical condition at any time during the study

• Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs

• Participated in an investigational drug trial within 3 months of screening

Study Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• dexmecamylamine

• Placebo

Locations

Country	Name	City	State
United States	The Urological Institute of Northeastern New York	Albany	New York
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	SouthWest Clinical Research	Albuquerque	New Mexico
United States	Atlanta Medical Research Institute	Alpharetta	Georgia
United States	Radiant Research, Inc.	Anderson	South Carolina
United States	Radiant Reseach, Inc.	Atlanta	Georgia
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Tekton Research, Inc.	Austin	Texas
United States	South Florida Medical Research	Aventura	Florida
United States	Urologic Consultants of SE PA	Bala Cynwyd	Pennsylvania
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Montana Health Research Institute, Inc.	Billings	Montana
United States	Simon-Williamson Clinic, P.C.	Birmingham	Alabama
United States	Fellows Research Alliance, Inc.	Bluffton	South Carolina
United States	Boston Clinical Trials, Inc.	Boston	Massachusetts
United States	Beacon Clinical Research, LLC	Brockton	Massachusetts
United States	Meridien Reseach	Brooksville	Florida
United States	DiscoverResearch, Inc.	Bryan	Texas
United States	Mississippi Medical Research, LLC	Carriere	Mississippi
United States	Research Across America	Carrollton	Texas
United States	Radiant Research, Inc.	Chandler	Arizona
United States	Medical Research South, LLC	Charleston	South Carolina
United States	Radiant Research, Inc.	Chicago	Illinois
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Southeast Regional Research Group	Columbus	Georgia
United States	3H Clinical Research Corporation	Coral Springs	Florida
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	Research Across America	Dallas	Texas
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	InFocus Clinical Research	Denver	Colorado
United States	Physician's Resource Group	Dothan	Alabama
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Radiant Research, Inc.	Edina	Minnesota
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	Advanced Urology Centers of New York	Garden City	New York
United States	Clinical Trials of Arizona, Inc.	Glendale	Arizona
United States	Family Medicine Specialists, PC	Grand Rapids	Michigan
United States	Mid Atlantic Urology Associates, LLC	Greenbelt	Maryland
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	Palm Spring Research Institute	Hialeah	Florida
United States	The Jackson Clinic	Jackson	Tennessee
United States	First Urology PSC	Jeffersonville	Indiana
United States	Advanced Therapeutics, Inc.	Johnson City	Tennessee
United States	Beyer Research	Kalamazoo	Michigan
United States	Westside Family Medical Center, PC	Kalamazoo	Michigan
United States	Center for Pharmaceutical Research	Kansas City	Missouri
United States	Premier Medical Group of the Hudson Valley, PC	Kingston	New York
United States	American Medical Research Institute	Kissimmee	Florida
United States	Altus Research	Lake Worth	Florida
United States	Sunrise Medical Research	Lauderdale Lakes	Florida
United States	Lawrence OB-GYN Clinical Research, LLC	Lawrenceville	New Jersey
United States	Women's Clinical of Lincoln, P.C.	Lincoln	Nebraska
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Atlantic Urology Medical Group	Long Beach	California
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Adam D. Karnes, MD	Los Angeles	California
United States	Bluegrass Clinical Research	Louisville	Kentucky
United States	Connecticut Clinical Research Center, LLC	Middlebury	Connecticut
United States	Five Valleys Urology	Missoula	Montana
United States	Coastal Clinical Research, Inc	Mobile	Alabama
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Mobile Ob-Gyn, P.C.	Mobile	Alabama
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Tennesse Women's Care	Nashville	Tennessee
United States	Advanced Research Institute, Inc.	New Port Richey	Florida
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Manhattan Medical Research Practice PLLC	New York	New York
United States	Deaconess Clinic Gateway Health Center	Newburgh	Indiana
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Clinical Research Associates of Tidewater, Inc.	Norfolk	Virginia
United States	The Group for Women	Norfolk	Virginia
United States	Quality Clinical Research, Inc.	Omaha	Nebraska
United States	Research Integrity, LLC	Owensboro	Kentucky
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Beach Clinical Studies	Phoenix	Arizona
United States	Clinical Research of Central Florida	Plant City	Florida
United States	Premier Medical Group of the Hudson Valley, PC	Poughkeepsie	New York
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Valley Women's Clinic	Renton	Washington
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Perimeter North Medical Research, Inc.	Roswell	Georgia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Northern California Research	Sacramento	California
United States	Saginaw Valley Medical Reseach Group, LLC	Saginaw	Michigan
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Quality Research Inc.	San Antonio	Texas
United States	Radiant Reseach, Inc.	San Antonio	Texas
United States	Genesis Research	San Diego	California
United States	San Diego Sexual Medicine	San Diego	California
United States	Fellows Research Alliance, Inc.	Savannah	Georgia
United States	Radiant Research, Inc.	Scottsdale	Arizona
United States	Seattle Women's Health, Research, Gynecology	Seattle	Washington
United States	GTC Research	Shawnee	Kansas
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Willis-Knighton Physician Network	Shreveport	Louisiana
United States	Hillcrest Clinical Research, LLC	Simpsonville	South Carolina
United States	Radiant Research, Inc.	St. Louis	Missouri
United States	Lakeview Medical Research	Summerfield	Florida
United States	Southeastern Research Group, Inc.	Tallahassee	Florida
United States	Westlake Medical Research	Thousand Oaks	California
United States	Genova Clinical Research, Inc.	Tucson	Arizona
United States	Radiant Research, Inc.	Tucson	Arizona
United States	Delaware Valley Urology, LLC	Voorhees	New Jersey
United States	Greater Providence Clinical Research, LLC	Warwick	Rhode Island
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Advanced Clinical Concepts	West Reading	Pennsylvania
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	Metro Urology	Woodbury	Minnesota
United States	North Georgia Clinical Research	Woodstock	Georgia
United States	Physicians' Research, Inc.	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in micturition frequency per 24 hours	Micturition: Any voiding episode recorded by the patient as "urinated" either with or without incontinence.	12 weeks	No
Primary	Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours		12 weeks	No
Secondary	Change from baseline in the volume voided per micturition		12 weeks	No
Secondary	Change from baseline in nocturia per 24 hours	Nocturia: A micturition that wakes the subject from sleep between the time the subject went to bed and the time the subject woke up.	12 weeks	No
Secondary	Clinical Global Impression of Improvement (CGI-I)		12 weeks	No
Secondary	Change from baseline in Patient Perception of Bladder Condition (PPBC)		12 weeks	No
Secondary	Change from baseline in the Urgency Questionnaire		12 weeks	No
Secondary	Change from baseline in disease specific quality of life (OABq)		12 weeks	No