Overactive Bladder
Conditions
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.
Interventions
DRUGdexmecamylamine
DRUGPlacebo
Sponsors
Targacept Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Urgency Questionnaire | 12 weeks | — |
| Change from baseline in the volume voided per micturition | 12 weeks | — |
| Clinical Global Impression of Improvement (CGI-I) | 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. |
| Change from baseline in disease specific quality of life (OABq) | 12 weeks | — |
| Change from baseline in Patient Perception of Bladder Condition (PPBC) | 12 weeks | — |
Countries
United States
Outcome results
None listed