Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Overactive Bladder Syndrome Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00335660
• Other study ID #: AV608-106
• Status: Terminated
• Phase: Phase 2
• First received: June 8, 2006
• Last updated: February 15, 2008
• Start date: June 2006
• Est. completion date: September 2007

Study information

• Verified date: February 2008
• Source: Avera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of AV608 in subjects with idiopathic detrusor overactivity. Female subjects between 18 and 65 years of age with a diagnosis of Overactive Bladder Syndrome and urodynamic observation of involuntary detrusor contractions during the filling phase will be eligible for the trial.

Eligible subjects will complete a baseline urodynamic assessment. All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo. At the end of the treatment period, subjects will complete a second urodynamic assessment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: September 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• AV608

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avera Pharmaceuticals

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity
Secondary	Delay of the first involuntary detrusor contraction associated with symptomatic urgency
Secondary	Urgency, frequency and urge incontinence events as recorded in the Subject Micturition Diary
Secondary	Urgency Perception Scale