Overactive Bladder SyndromePhase 2NCT00335660
Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity
A Phase 2 study testing AV608 in people with Overactive Bladder Syndrome, run by Avera Pharmaceuticals at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- AV608
- How many people
- 62 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jun 2006to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United Kingdom10 sites
Study site
Birmingham, England
Study site
Blackburn, England
Study site
Chertsey, England
Study site
Falkirk, Scotland
Study site
Hull, England
Study site
Leeds, England
Study site
Liverpool, England
Study site
London, England
Study site
Plymouth, England
Study site
Sheffield, England
Netherlands3 sites
Study site
Amsterdam
Study site
Nieuwegein
Study site
Zeist
About this study
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
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.
Read the 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.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- AV608
- Keywords
- Idiopathic Detrusor Overactivity, NK-1 Receptor Antagonist, Neurokinin, Urge Incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV608Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2007
- Study completionSep 2007
Why it stopped: Animal Safety Data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Linda Cardozo, MD FRCOG, Principal investigator, King's College Hospital NHS TrustJoao Siffert, MD, Study director, Avera Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335660
- Sponsor's protocol ID
- AV608-106
- Status last verified
- Feb 2008
- First submitted
- 8 Jun 2006
- Last updated
- 25 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00335660
- Acronym / sponsor ID
- AV608-106
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Idiopathic Detrusor Overactivity, NK-1 Receptor Antagonist, Neurokinin, Urge Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Animal Safety Data
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Avera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV608 | Drug | – |
Primary outcome
Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Animal Safety Data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Cardozo, MD FRCOG principal investigator
King's College Hospital NHS Trust
Joao Siffert, MD study director
Avera Pharmaceuticals, Inc.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AV608 in people with Overactive Bladder Syndrome, run by Avera Pharmaceuticals at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Animal Safety Data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between treatment groups of the change from baseline in maximum cystometric bladder capacity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2008.