Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.

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Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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UISH001

Group Type EXPERIMENTAL

UISH001

Intervention Type DRUG

sublingual dosing, 1 drop 3 times a day

Matching placebo

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DRUG

sublingual dosing,1 drop 3 times a day

Interventions

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UISH001

sublingual dosing, 1 drop 3 times a day

Intervention Type DRUG

matching placebo

sublingual dosing,1 drop 3 times a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women who have moderate to severe urge, stress or mixed Urinary Incontinence

Exclusion Criteria

* Medical history of migraines, neurologic problems, swallowing disorder, stroke or severe depression.
* Medical history of heart failure, peripheral edema or moderate to severe asthma or chronic obstructive pulmonary disease (COPD)
* Certain restricted medications
* Any other condition that would interfere with the safety of the subject

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No