Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
This study has been terminated.
(Animal Safety Data)
Sponsor:
Avera Pharmaceuticals
Information provided by:
Avera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00335660
First received: June 8, 2006
Last updated: February 15, 2008
Last verified: February 2008
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Purpose
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder Syndrome |
Drug: AV608 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Further study details as provided by Avera Pharmaceuticals:
Primary Outcome Measures:
- Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity
Secondary Outcome Measures:
- Delay of the first involuntary detrusor contraction associated with symptomatic urgency
- Urgency, frequency and urge incontinence events as recorded in the Subject Micturition Diary
- Urgency Perception Scale
| Estimated Enrollment: | 62 |
| Study Start Date: | June 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335660
Locations
| Netherlands | |
| Amsterdam, Netherlands | |
| Nieuwegein, Netherlands | |
| Zeist, Netherlands | |
| United Kingdom | |
| Birmingham, England, United Kingdom | |
| Blackburn, England, United Kingdom | |
| Chertsey, England, United Kingdom | |
| Hull, England, United Kingdom | |
| Leeds, England, United Kingdom | |
| Liverpool, England, United Kingdom | |
| London, England, United Kingdom | |
| Plymouth, England, United Kingdom | |
| Sheffield, England, United Kingdom | |
| Falkirk, Scotland, United Kingdom | |
Sponsors and Collaborators
Avera Pharmaceuticals
Investigators
| Principal Investigator: | Linda Cardozo, MD FRCOG | King's College Hospital NHS Trust |
| Study Director: | Joao Siffert, MD | Avera Pharmaceuticals, Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00335660 History of Changes |
| Other Study ID Numbers: | AV608-106 |
| Study First Received: | June 8, 2006 |
| Last Updated: | February 15, 2008 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Avera Pharmaceuticals:
|
Idiopathic Detrusor Overactivity NK-1 Receptor Antagonist Neurokinin Urge Incontinence |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013