A double-blind, placebo controlled study to assess the safety and preliminary efficacy of PSD506 in treatment-naïve or previously treated (washed out) patients symptoms of overactive bladder (OAB)

PLETHORA SOLUTIONS LIMITED0 sites112 target enrollmentSeptember 18, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 18, 2006

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•The study population is subjects with symptoms of overactive bladder (OAB) as defined by the International Continence Society (ICS).
•Inclusion Criteria:
•1\. Age 18 years or over.
•2\. If female, must be surgically sterile or post\-menopausal for at least a year and confirmed by a negative hormone panel (luteinizing hormone \[LH], follicle stimulating hormone \[FSH], 17ß estradiol.
•3\. If male subject and partner is of child bearing potential must agree to use a secure form of contraception (e.g. pill, condom).
•4\. Involuntary detrusor contraction associated with urgency during filling cystometry in the last 6 months prior to study entry.
•5\. Symptoms of OAB for at least 6 months prior to study entry.
•6\. Willing and able to provide written informed consent.
•Inclusion criteria at baseline:
•7\. Completed appropriate washout period (for previously treated subjects) and 7 days run\-in period for all subjects (both treated subjects and treatment naïve subjects) prior to Baseline Visit.

•1\. Female subject who is of child\-bearing potential.
•2\. Uncontrolled hypertension, defined as mean systolic blood pressure \[SBP] \=160mmHg or a diastolic blood pressure \[DBP] \=95mmHg (after sitting for 5 minutes).
•3\. History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness.
•4\. Unstable cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure.
•5\. Clinically significant central nervous system disease, including: Parkinson’s disease, multiple sclerosis, transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances.
•6\. History of peripheral vascular or cerebrovascular disease.
•7\. History of narrow angle glaucoma or increased ocular pressure.
•8\. Clinically significant bladder pathology (e.g., obstructive uropathy) or history of urinary retention.
•9\. Clinically significant gastrointestinal disorder (e.g., gastroparesis, constipation, diarrhea, colitis, gastrointestinal tract obstruction, hiatal hernia with reflux oesophagitis, cholestasis).
•10\. History of liver disease, e.g., hepatitis.