Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

This study has been terminated.
(Animal Safety Data)
Sponsor:
Information provided by:
Avera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00335660
First received: June 8, 2006
Last updated: February 15, 2008
Last verified: February 2008
  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

Resource links provided by NLM:


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)
Detailed 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014