Clinical trial NCT01868516: Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Targacept Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 1635
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in micturition frequency per 24 hours
timeFrame: 12 weeks
measure: Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in the volume voided per micturition
timeFrame: 12 weeks
measure: Change from baseline in nocturia per 24 hours
timeFrame: 12 weeks
measure: Clinical Global Impression of Improvement (CGI-I)
timeFrame: 12 weeks
measure: Change from baseline in Patient Perception of Bladder Condition (PPBC)
timeFrame: 12 weeks
measure: Change from baseline in the Urgency Questionnaire
timeFrame: 12 weeks
measure: Change from baseline in disease specific quality of life (OABq)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Simon-Williamson Clinic, P.C.
state: Alabama
city: Dothan
country: United States
facility: Physician's Resource Group
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc
state: Alabama
city: Mobile
country: United States
facility: Mobile Ob-Gyn, P.C.
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Glendale
country: United States
facility: Clinical Trials of Arizona, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Beach Clinical Studies
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Los Angeles
country: United States
facility: Adam D. Karnes, MD
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: San Diego
country: United States
facility: Genesis Research
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical Research
state: California
city: Denver
country: United States
facility: InFocus Clinical Research
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center, LLC
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Reseach
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Coral Springs
country: United States
facility: 3H Clinical Research Corporation
state: Florida
city: Hialeah
country: United States
facility: Palm Spring Research Institute
state: Florida
city: Kissimmee
country: United States
facility: American Medical Research Institute
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Plant City
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Summerfield
country: United States
facility: Lakeview Medical Research
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Research Group, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Radiant Reseach, Inc.
state: Georgia
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Roswell
country: United States
facility: Perimeter North Medical Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc.
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Chicago
country: United States
facility: Radiant Research, Inc.
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic Gateway Health Center
state: Indiana
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Shawnee
country: United States
facility: GTC Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Louisville
country: United States
facility: Bluegrass Clinical Research
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: Greenbelt
country: United States
facility: Mid Atlantic Urology Associates, LLC
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials, Inc.
state: Massachusetts
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Grand Rapids
country: United States
facility: Family Medicine Specialists, PC
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, PC
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Reseach Group, LLC
state: Michigan
city: Edina
country: United States
facility: Radiant Research, Inc.
state: Minnesota
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
city: Carriere
country: United States
facility: Mississippi Medical Research, LLC
state: Mississippi
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Billings
country: United States
facility: Montana Health Research Institute, Inc.
state: Montana
city: Missoula
country: United States
facility: Five Valleys Urology
state: Montana
city: Lincoln
country: United States
facility: Women's Clinical of Lincoln, P.C.
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence OB-GYN Clinical Research, LLC
state: New Jersey
city: Voorhees
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: SouthWest Clinical Research
state: New Mexico
city: Albany
country: United States
facility: The Urological Institute of Northeastern New York
state: New York
city: Garden City
country: United States
facility: Advanced Urology Centers of New York
state: New York
city: Kingston
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Zanesville
country: United States
facility: Physicians' Research, Inc.
state: Ohio
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia, LLC
state: Pennsylvania
city: West Reading
country: United States
facility: Advanced Clinical Concepts
state: Pennsylvania
city: Warwick
country: United States
facility: Greater Providence Clinical Research, LLC
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Bluffton
country: United States
facility: Fellows Research Alliance, Inc.
state: South Carolina
city: Charleston
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research, LLC
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Johnson City
country: United States
facility: Advanced Therapeutics, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Tennesse Women's Care
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Bryan
country: United States
facility: DiscoverResearch, Inc.
state: Texas
city: Carrollton
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Reseach, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater, Inc.
state: Virginia
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
city: Renton
country: United States
facility: Valley Women's Clinic
state: Washington
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology
state: Washington
Study officials:
References: