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



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/1/2014
Start Date:May 2013
End Date:July 2014
Contact:Recruitment Call Center
Email:SedonaCallCenter@unitedbiosource.com
Phone:855-526-6257

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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.


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
We found this trial at
127
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
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Missoula, Montana 59802
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400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Alpharetta, Georgia 30005
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Anderson, South Carolina 29621
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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Nashville, Tennessee 37203
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
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