MedDataX Logo

Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

NCT ID: NCT01089751

Last Updated: 2013-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sanctura XR®

Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.

Group Type EXPERIMENTAL

trospium chloride

Intervention Type DRUG

Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks

Placebo

Placebo once daily on an empty stomach for 14 weeks.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo once daily on an empty stomach for 14 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

trospium chloride

Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks

Intervention Type DRUG

placebo

Placebo once daily on an empty stomach for 14 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sanctura XR®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
* Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
* Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).

Exclusion Criteria

* Predominant stress or insensate incontinence
* History of neurogenic bladder
* Two urinary tract infections in the last six months
* Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
* Donated \>500mL blood in the 30 days prior to the screening visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

La Mesa, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GMA-SXR-09-004

Identifier Type: -

Identifier Source: org_study_id