Status:
COMPLETED
Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder
Lead Sponsor:
Targacept Inc.
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 saf...
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, ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
1635 Patients enrolled
Trial Details
Trial ID
NCT01868516
Start Date
May 1 2013
End Date
June 1 2014
Last Update
June 3 2015
Active Locations (125)
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1
Simon-Williamson Clinic, P.C.
Birmingham, Alabama, United States, 35209
2
Physician's Resource Group
Dothan, Alabama, United States, 36305
3
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 33324
4
Coastal Clinical Research, Inc
Mobile, Alabama, United States, 36608