Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder
1 other identifier
interventional
1,635
1 country
125
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2013
Shorter than P25 for phase_2
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
June 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 3, 2015
August 1, 2014
1.1 years
May 30, 2013
May 11, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours
12 weeks
Secondary Outcomes (6)
Change from baseline in the volume voided per micturition
12 weeks
Change from baseline in nocturia per 24 hours
12 weeks
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
- +1 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATOROne tablet of placebo to be administered orally twice a day.
0.5 mg dexmecamylamine (TC-5214)
EXPERIMENTALOne tablet of 0.5 mg dexmecamylamine to be administered orally twice a day.
1 mg dexmecamylamine (TC-5214)
EXPERIMENTALOne tablet of 1 mg dexmecamylamine to be administered orally twice a day.
2 mg dexmecamylamine (TC-5214)
EXPERIMENTALOne tablet of 2 mg dexmecamylamine to be administered orally twice a day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Targacept Inc.lead
Study Sites (125)
Simon-Williamson Clinic, P.C.
Birmingham, Alabama, 35209, United States
Physician's Resource Group
Dothan, Alabama, 36305, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 33324, United States
Coastal Clinical Research, Inc
Mobile, Alabama, 36608, United States
Mobile Ob-Gyn, P.C.
Mobile, Alabama, 36608, United States
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
Clinical Trials of Arizona, Inc.
Glendale, Arizona, 85306, United States
Beach Clinical Studies
Phoenix, Arizona, 85051, United States
Radiant Research, Inc.
Scottsdale, Arizona, 85251, United States
Genova Clinical Research, Inc.
Tucson, Arizona, 85704, United States
Radiant Research, Inc.
Tucson, Arizona, 85710, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Atlantic Urology Medical Group
Long Beach, California, 90806, United States
Adam D. Karnes, MD
Los Angeles, California, 90036, United States
Tri Valley Urology Medical Group
Murrieta, California, 92562, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Northern California Research
Sacramento, California, 95821, United States
San Diego Sexual Medicine
San Diego, California, 92120, United States
Genesis Research
San Diego, California, 92123, United States
Westlake Medical Research
Thousand Oaks, California, 91360, United States
InFocus Clinical Research
Denver, Colorado, 80211, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032, United States
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, 06762, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Meridien Reseach
Brooksville, Florida, 34601, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
3H Clinical Research Corporation
Coral Springs, Florida, 33065, United States
Palm Spring Research Institute
Hialeah, Florida, 33012, United States
American Medical Research Institute
Kissimmee, Florida, 34741, United States
Altus Research
Lake Worth, Florida, 33461, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653, United States
Clinical Research of Central Florida
Plant City, Florida, 33563, United States
Lakeview Medical Research
Summerfield, Florida, 34491, United States
Southeastern Research Group, Inc.
Tallahassee, Florida, 32308, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005, United States
Radiant Reseach, Inc.
Atlanta, Georgia, 30342, United States
Southeast Regional Research Group
Columbus, Georgia, 31904, United States
Perimeter North Medical Research, Inc.
Roswell, Georgia, 30076, United States
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
Radiant Research, Inc.
Chicago, Illinois, 60654, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
First Urology PSC
Jeffersonville, Indiana, 47130, United States
Deaconess Clinic Gateway Health Center
Newburgh, Indiana, 47630, United States
Heartland Research Associates, LLC
Augusta, Kansas, 67010, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
GTC Research
Shawnee, Kansas, 66218, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Bluegrass Clinical Research
Louisville, Kentucky, 40291, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, 71115, United States
Mid Atlantic Urology Associates, LLC
Greenbelt, Maryland, 20770, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, 02131, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472, United States
Family Medicine Specialists, PC
Grand Rapids, Michigan, 49544, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Westside Family Medical Center, PC
Kalamazoo, Michigan, 49009, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Saginaw Valley Medical Reseach Group, LLC
Saginaw, Michigan, 48604, United States
Radiant Research, Inc.
Edina, Minnesota, 55435, United States
Metro Urology
Woodbury, Minnesota, 55125, United States
Mississippi Medical Research, LLC
Carriere, Mississippi, 39426, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Radiant Research, Inc.
St Louis, Missouri, 63141, United States
Montana Health Research Institute, Inc.
Billings, Montana, 59102, United States
Five Valleys Urology
Missoula, Montana, 59808, United States
Women's Clinical of Lincoln, P.C.
Lincoln, Nebraska, 68510, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Lawrence OB-GYN Clinical Research, LLC
Lawrenceville, New Jersey, 08648, United States
Delaware Valley Urology, LLC
Voorhees Township, New Jersey, 08043, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
SouthWest Clinical Research
Albuquerque, New Mexico, 87109, United States
The Urological Institute of Northeastern New York
Albany, New York, 12208, United States
Advanced Urology Centers of New York
Garden City, New York, 11530, United States
Premier Medical Group of the Hudson Valley, PC
Kingston, New York, 12401, United States
Manhattan Medical Research Practice PLLC
New York, New York, 10016, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45249, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Radiant Research, Inc.
Columbus, Ohio, 43212, United States
Physicians' Research, Inc.
Zanesville, Ohio, 43701, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Advanced Clinical Concepts
West Reading, Pennsylvania, 19611, United States
Greater Providence Clinical Research, LLC
Warwick, Rhode Island, 02888, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Fellows Research Alliance, Inc.
Bluffton, South Carolina, 29910, United States
Medical Research South, LLC
Charleston, South Carolina, 29407, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, 29681, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
The Jackson Clinic
Jackson, Tennessee, 38305, United States
Advanced Therapeutics, Inc.
Johnson City, Tennessee, 37601, United States
Tennesse Women's Care
Nashville, Tennessee, 37203, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
DiscoverResearch, Inc.
Bryan, Texas, 77802, United States
Research Across America
Carrollton, Texas, 75010, United States
Research Across America
Dallas, Texas, 75234, United States
DCOL Center for Clinical Research
Longview, Texas, 75605, United States
Quality Research Inc.
San Antonio, Texas, 78209, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Radiant Reseach, Inc.
San Antonio, Texas, 78229, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
The Group for Women
Norfolk, Virginia, 23502, United States
Clinical Research Associates of Tidewater, Inc.
Norfolk, Virginia, 23507, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
Valley Women's Clinic
Renton, Washington, 98055, United States
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2013
First Posted
June 4, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 3, 2015
Record last verified: 2014-08