Back to resultsSafety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)
Primary Purpose
Urinary Incontinence, Overactive Bladder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0594
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The incidence of dry mouth.
The incidence of dry mouth.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00290563
Brief Title
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)
Official Title
A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 21, 2006 (Actual)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 24, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyne Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
557 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0594
Primary Outcome Measure Information:
Title
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Description
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
Time Frame
Duration of Trial
Secondary Outcome Measure Information:
Title
The incidence of dry mouth.
Description
The incidence of dry mouth.
Time Frame
Duration of Treatment
Title
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
Description
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.
Time Frame
Duration of Treatment
Title
Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms.
Description
Global assessment of improvement in UI, perception of urgency, and bother of UI
Time Frame
Duration of Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
20639026
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)
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