NCT00335660

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 25, 2008

Status Verified

February 1, 2008

Enrollment Period

1 year

First QC Date

June 8, 2006

Last Update Submit

February 15, 2008

Conditions

Overactive Bladder Syndrome

Keywords

Idiopathic Detrusor OveractivityNK-1 Receptor AntagonistNeurokininUrge Incontinence

Outcome Measures

Primary Outcomes (1)

  • Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity

Secondary Outcomes (3)

  • 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

Interventions

AV608DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Nieuwegein, Netherlands

Location

Unknown Facility

Zeist, Netherlands

Location

Unknown Facility

Birmingham, England, United Kingdom

Location

Unknown Facility

Blackburn, England, United Kingdom

Location

Unknown Facility

Chertsey, England, United Kingdom

Location

Unknown Facility

Hull, England, United Kingdom

Location

Unknown Facility

Leeds, England, United Kingdom

Location

Unknown Facility

Liverpool, England, United Kingdom

Location

Unknown Facility

London, England, United Kingdom

Location

Unknown Facility

Plymouth, England, United Kingdom

Location

Unknown Facility

Sheffield, England, United Kingdom

Location

Unknown Facility

Falkirk, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Linda Cardozo, MD FRCOG

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

  • Joao Siffert, MD

    Avera Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 8, 2006

First Posted

June 12, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2007

Study Completion

September 1, 2007

Last Updated

February 25, 2008

Record last verified: 2008-02

Locations

NL(3)GB(10)