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

Phase 2

Completed

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

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

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

Locations (110): Simon-Williamson Clinic, P.C.
🇺🇸
Birmingham, Alabama, United States
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.
🇺🇸
Anderson, South Carolina, United States
Clinical Trials of Arizona, Inc.
🇺🇸
Glendale, Arizona, United States
Beach Clinical Studies
🇺🇸
Phoenix, Arizona, United States
Genova Clinical Research, Inc.
🇺🇸
Tucson, Arizona, United States
Lynn Institute of the Ozarks
🇺🇸
Little Rock, Arkansas, United States
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Simon-Williamson Clinic, P.C.
🇺🇸Birmingham, Alabama, United States