Urinary IncontinencePhase 2NCT00290563
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)
A Phase 2 study testing MK0594 in people with Urinary Incontinence and Overactive Bladder, run by Vyne Therapeutics Inc..
Trial summary
This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Urinary Incontinence, Overactive Bladder
- What is being tested?
- MK0594
- How many people
- 557 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2006to 24 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with predominantly urge incontinence overactive bladder episodes
- Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards
Who cannot join
- History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia
- Lower urinary tract symptoms associated with benign prostatic hypertrophy
- Active or current Urinary Tract Infections (UTIs)
- Surgery to correct prolapsed uterus or stress incontinence
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder
This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.
- Conditions
- Urinary Incontinence, Overactive Bladder
- Being tested
- MK0594
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0594Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Measured: Duration of Trial
Secondary outcomes (3)
The incidence of dry mouth.
The incidence of dry mouth.
Measured: Duration of Treatment
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
Measured: Duration of Treatment
Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms.
Global assessment of improvement in UI, perception of urgency, and bother of UI
Measured: Duration of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study start21 Feb 2006
- Primary completionAug 2007
- Study completion24 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyne Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290563
- Sponsor's protocol ID
- 0594-003
- Other IDs
- MK0594-003, 2005_102
- Status last verified
- May 2021
- First submitted
- 10 Feb 2006
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Frenkl TL, Zhu H, Reiss T, Seltzer O, Rosenberg E, Green S. A multicenter, double-blind, randomized, placebo controlled trial of a neurokinin-1 receptor antagonist for overactive bladder. J Urol. 2010 Aug;184(2):616-22. doi: 10.1016/j.juro.2010.03.147. Epub 2010 Jun 19.
PubMed 20639026
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00290563
- Acronym / sponsor ID
- 0594-003
- Conditions
- Urinary Incontinence, Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Vyne Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2006 (actual)
- Primary completion
- Aug 2007 (actual)
- Study completion
- 24 Sep 2007 (actual)
- First posted
- 13 Feb 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.
This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with predominantly urge incontinence overactive bladder episodes
- Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards
Key exclusion criteria (4 listed)
- History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia
- Lower urinary tract symptoms associated with benign prostatic hypertrophy
- Active or current Urinary Tract Infections (UTIs)
- Surgery to correct prolapsed uterus or stress incontinence
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 |
|---|---|---|
| MK0594 | Drug | – |
Primary outcome
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Time frame: Duration of Trial
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
3 secondary outcomes
The incidence of dry mouth.
Time frame: Duration of Treatment
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
Time frame: Duration of Treatment
Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms.
Time frame: Duration of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 20639026Frenkl TL, Zhu H, Reiss T, Seltzer O, Rosenberg E, Green S. A multicenter, double-blind, randomized, placebo controlled trial of a neurokinin-1 receptor antagonist for overactive bladder. J Urol. 2010 Aug;184(2):616-22. doi: 10.1016/j.juro.2010.03.147. Epub 2010 Jun 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0594 in people with Urinary Incontinence and Overactive Bladder, run by Vyne Therapeutics Inc..
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in baseline in average daily micturitions as recorded on patient voiding diaries. (time frame: Duration of Trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00290563, which also lists 1 linked publication.
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 19 May 2021.