Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder
- Registration Number
- NCT01868516
- Lead Sponsor
- Targacept Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1635
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.5 mg dexmecamylamine (TC-5214) dexmecamylamine One tablet of 0.5 mg dexmecamylamine to be administered orally twice a day. Placebo Placebo One tablet of placebo to be administered orally twice a day. 2 mg dexmecamylamine (TC-5214) dexmecamylamine One tablet of 2 mg dexmecamylamine to be administered orally twice a day. 1 mg dexmecamylamine (TC-5214) dexmecamylamine One tablet of 1 mg dexmecamylamine to be administered orally twice a day.
- Primary Outcome Measures
Name Time Method Change from baseline in micturition frequency per 24 hours 12 weeks Micturition: Any voiding episode recorded by the patient as "urinated" either with or without incontinence.
Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in the volume voided per micturition 12 weeks Change from baseline in nocturia per 24 hours 12 weeks Nocturia: A micturition that wakes the subject from sleep between the time the subject went to bed and the time the subject woke up.
Clinical Global Impression of Improvement (CGI-I) 12 weeks Change from baseline in Patient Perception of Bladder Condition (PPBC) 12 weeks Change from baseline in the Urgency Questionnaire 12 weeks Change from baseline in disease specific quality of life (OABq) 12 weeks
Trial Locations
- Locations (110)
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Westside Family Medical Center, PC
🇺🇸Kalamazoo, Michigan, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Mobile Ob-Gyn, P.C.
🇺🇸Mobile, Alabama, United States
Center for Clinical Trials, LLC
🇺🇸Paramount, California, United States
Atlantic Urology Medical Group
🇺🇸Long Beach, California, United States
Tampa Bay Medical Research
🇺🇸Clearwater, Florida, United States
American Medical Research Institute
🇺🇸Kissimmee, Florida, United States
Sunrise Medical Research
🇺🇸Lauderdale Lakes, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Meridien Reseach
🇺🇸Brooksville, Florida, United States
Lakeview Medical Research
🇺🇸Summerfield, Florida, United States
Deaconess Clinic Gateway Health Center
🇺🇸Newburgh, Indiana, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Willis-Knighton Physician Network
🇺🇸Shreveport, Louisiana, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Mid Atlantic Urology Associates, LLC
🇺🇸Greenbelt, Maryland, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
Family Medicine Specialists, PC
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Metro Urology
🇺🇸Woodbury, Minnesota, United States
Advanced Urology Centers of New York
🇺🇸Garden City, New York, United States
Clinical Research of Philadelphia, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Greater Providence Clinical Research, LLC
🇺🇸Warwick, Rhode Island, United States
Advanced Clinical Concepts
🇺🇸West Reading, Pennsylvania, United States
Clinical Research Associates of Tidewater, Inc.
🇺🇸Norfolk, Virginia, United States
Delaware Valley Urology, LLC
🇺🇸Voorhees, New Jersey, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Women's Clinical of Lincoln, P.C.
🇺🇸Lincoln, Nebraska, United States
Lawrence OB-GYN Clinical Research, LLC
🇺🇸Lawrenceville, New Jersey, United States
Genova Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Connecticut Clinical Research Center, LLC
🇺🇸Middlebury, Connecticut, United States
Simon-Williamson Clinic, P.C.
🇺🇸Birmingham, Alabama, United States
San Diego Sexual Medicine
🇺🇸San Diego, California, United States
Tennesse Women's Care
🇺🇸Nashville, Tennessee, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
InFocus Clinical Research
🇺🇸Denver, Colorado, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Physician's Resource Group
🇺🇸Dothan, Alabama, United States
Radiant Research, Inc.
🇺🇸Anderson, South Carolina, United States
Coastal Clinical Research, Inc
🇺🇸Mobile, Alabama, United States
Clinical Trials of Arizona, Inc.
🇺🇸Glendale, Arizona, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Beach Clinical Studies
🇺🇸Phoenix, Arizona, United States
Genesis Research
🇺🇸San Diego, California, United States
Women's Health Specialty Care
🇺🇸Farmington, Connecticut, United States
Adam D. Karnes, MD
🇺🇸Los Angeles, California, United States
Tri Valley Urology Medical Group
🇺🇸Murrieta, California, United States
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Atlanta Medical Research Institute
🇺🇸Alpharetta, Georgia, United States
Fellows Research Alliance, Inc.
🇺🇸Bluffton, South Carolina, United States
Boston Clinical Trials, Inc.
🇺🇸Boston, Massachusetts, United States
Mississippi Medical Research, LLC
🇺🇸Carriere, Mississippi, United States
Five Valleys Urology
🇺🇸Missoula, Montana, United States
Montana Health Research Institute, Inc.
🇺🇸Billings, Montana, United States
Premier Medical Group of the Hudson Valley, PC
🇺🇸Poughkeepsie, New York, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
The Urological Institute of Northeastern New York
🇺🇸Albany, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Hillcrest Clinical Research, LLC
🇺🇸Simpsonville, South Carolina, United States
Research Across America
🇺🇸Dallas, Texas, United States
DiscoverResearch, Inc.
🇺🇸Bryan, Texas, United States
Quality Research Inc.
🇺🇸San Antonio, Texas, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Seattle Women's Health, Research, Gynecology
🇺🇸Seattle, Washington, United States
Integrity Medical Research, LLC
🇺🇸Mountlake Terrace, Washington, United States
Valley Women's Clinic
🇺🇸Renton, Washington, United States
Palm Spring Research Institute
🇺🇸Hialeah, Florida, United States
3H Clinical Research Corporation
🇺🇸Coral Springs, Florida, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
Southeastern Research Group, Inc.
🇺🇸Tallahassee, Florida, United States
Radiant Reseach, Inc.
🇺🇸San Antonio, Texas, United States
Southeast Regional Research Group
🇺🇸Columbus, Georgia, United States
Clinical Investigation Specialists, Inc.
🇺🇸Gurnee, Illinois, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
First Urology PSC
🇺🇸Jeffersonville, Indiana, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Saginaw Valley Medical Reseach Group, LLC
🇺🇸Saginaw, Michigan, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Urologic Consultants of SE PA
🇺🇸Bala Cynwyd, Pennsylvania, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
The Group for Women
🇺🇸Norfolk, Virginia, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
Perimeter North Medical Research, Inc.
🇺🇸Roswell, Georgia, United States
Physicians' Research, Inc.
🇺🇸Zanesville, Ohio, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Northern California Research
🇺🇸Sacramento, California, United States
Bluegrass Clinical Research
🇺🇸Louisville, Kentucky, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
SouthWest Clinical Research
🇺🇸Albuquerque, New Mexico, United States
Medical Research South, LLC
🇺🇸Charleston, South Carolina, United States
Tekton Research, Inc.
🇺🇸Austin, Texas, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
Advanced Therapeutics, Inc.
🇺🇸Johnson City, Tennessee, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Westlake Medical Research
🇺🇸Thousand Oaks, California, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
GTC Research
🇺🇸Shawnee, Kansas, United States