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

Urinary Incontinence Clinical Trial

Official title:

A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of UISH001 for the Symptomatic Improvement of Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340066
• Other study ID #: 03-2006-0081
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 18, 2011
• Last updated: March 22, 2013
• Start date: April 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Beech Tree Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Drug:
• UISH001
sublingual dosing, 1 drop 3 times a day
• matching placebo
sublingual dosing,1 drop 3 times a day

Locations

Country	Name	City	State
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Rochester Clinical Research	Rochester	New York
United States	PEAK Research, LLC	Upper St. Clair	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Beech Tree Labs, Inc.	Norwich Clinical Research Associates Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Decrease in Leakage Events of 30% or More.	Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period.	Change from baseline after 4 weeks of treatment.	No