A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder

NCT ID: NCT00501267

Last Updated: 2015-04-15

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

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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solabegron and oxybutynin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult males \& females ages 18-65;
* Body weight \>50kg; BMI between 19-32;
* Signed and dated informed consent; QTc Interval \<450 msec;

Exclusion Criteria

* Resting blood pressure \>140/90 mmHg or HR \>100 at screening;
* History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
* Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
* Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
* history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
* history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
* clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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B3C109868

Identifier Type: -

Identifier Source: org_study_id

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