Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

• Status: Terminated
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avera Pharmaceuticals

Criteria

Inclusion Criteria:

• Female, 18 to 65 years of age, inclusive

• A current primary diagnosis of OAB

• Idiopathic detrusor overactivity, demonstrated by a urodynamic observation

• Evidence of frequency in combination with urinary urgency

• Written informed consent form

• Willingness to avoid pregnancy and practice adequate birth control

• Negative serum pregnancy test

• Agrees to refrain from blood donation during the course of the study

Exclusion Criteria:

• Subjects who are pregnant or lactating

• Clinically significant abnormality or clinically significant unstable medical condition

• QTc interval of 470 msec or greater at Visit 1

• Predominant stress urinary incontinence versus urge urinary incontinence based on subject history

• Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis, etc.)

• Anatomic or structural abnormalities possibly causing urinary incontinence or urgency, including but not limited to urogenital prolapse stage 2 or more according to the Pelvic Organ Prolapse Quantification (POP-Q) system

• Urological or gynecological surgery within 3 months of the baseline urodynamic assessment

• Current UTI or frequent UTIs (i.e., greater than or equal to 4 UTIs per year), interstitial cystitis, hematuria of unknown cause, or use of indwelling catheter

• Electro-stimulation therapy, bladder training, or physiotherapy for bladder control within 2 weeks of Visit 1

• History (within 1 year of Screening) of alcohol or substance dependence (except nicotine dependence) according to DSM-IV-TR criteria

• History of any kind of cancer within the last 2 years

• Existing non-malignant tumors that could compromise the function and/or anatomy of the lower urinary tract