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

Completed · Phase 2 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT01868516

Run by

Targacept Inc.

People needed

1635

Starts

2013-05-01

Expected to finish

2014-06-01

Last updated by the study team

2015-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Physician's Resource Group — Dothan, Alabama, 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
• Radiant Research, Inc. — Chandler, Arizona, United States
• Clinical Trials of Arizona, Inc. — Glendale, Arizona, United States
• Beach Clinical Studies — Phoenix, Arizona, United States
• Radiant Research, Inc. — Scottsdale, Arizona, United States
• Genova Clinical Research, Inc. — Tucson, Arizona, United States
• Radiant Research, Inc. — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Atlantic Urology Medical Group — Long Beach, California, United States
• Adam D. Karnes, MD — Los Angeles, California, United States
• Tri Valley Urology Medical Group — Murrieta, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Northern California Research — Sacramento, California, United States
• San Diego Sexual Medicine — San Diego, California, United States
• Genesis Research — San Diego, California, United States
• Westlake Medical Research — Thousand Oaks, California, United States
• InFocus Clinical Research — Denver, Colorado, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Women's Health Specialty Care — Farmington, Connecticut, United States
• Connecticut Clinical Research Center, LLC — Middlebury, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Simon-Williamson Clinic, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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