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

March 22, 2013 updated by: Beech Tree Labs, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Endwell, New York, United States, 13760
        • Regional Clinical Research, Inc.
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • Pennsylvania
      • Upper St. Clair, Pennsylvania, United States, 15241
        • PEAK Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Matching placebo
Drug: matching placebo
sublingual dosing,1 drop 3 times a day
Experimental: UISH001
Drug: UISH001
sublingual dosing, 1 drop 3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Decrease in Leakage Events of 30% or More.
Time Frame: Change from baseline after 4 weeks of treatment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beech Tree Labs, Inc.

Collaborators

Norwich Clinical Research Associates Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 20, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

March 22, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-2006-0081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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