Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)

NCT ID: NCT00290563

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

557 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-21

Study Completion Date

2007-09-24

Brief Summary

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This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.

Detailed Description

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Conditions

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Urinary Incontinence Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0594

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 20639026 (View on PubMed)

Other Identifiers

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MK0594-003

Identifier Type: -

Identifier Source: secondary_id

2005_102

Identifier Type: -

Identifier Source: secondary_id

0594-003

Identifier Type: -

Identifier Source: org_study_id

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