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NCT01945489 · ClinicalTrials.gov registry record · Phase 4

OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

A Phase 4 study of Overactive Bladder, sponsored by Allergan.

Completed
Registry status
Phase 4
Development phase
254
Enrollment target
20
Study locations

NCT01945489 is a Phase 4 study of Overactive Bladder that has completed, run by Allergan. The registered enrollment target is 254 participants, above the 206-participant average among 45 other Overactive Bladder trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT01945489, a Phase 4 study of Overactive Bladder, has completed, sponsored by Allergan.

COMPLETED
Registry status
Phase 4
Development phase
254 participants
Enrollment target
20
Study locations

Study Summary

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Conditions Studied

Overactive Bladder

Interventions

  • DRUG Normal saline
  • BIOLOGICAL onabotulinumtoxinA

Study Locations (20)

Florida

  • Sunrise Medical Research - Lauderdale Lakes
  • Bladder and Prostate Health Investigations, LLC - Miramar
  • Renstar Medical Research - Ocala
  • Urology Health Team, PLLC - Ocala
  • Southeastern Research Group, Inc. - Tallahassee

Indiana

  • Northeast Indiana - Fort Wayne
  • Urogynecology Associates - Indianapolis
  • Deaconess Clinic, Inc. - Newburgh
  • Urology of Indiana, LLC - Noblesville

California

  • South Orange County Medical Research Center - Laguna Hills
  • University of Southern California - Los Angeles
  • Genesis Research LLC - San Diego

Colorado

  • U. Colorado, School of Med. - Aurora
  • Genitourinary Surgical Consultants - Denver

Alabama

  • Urologic Clinics of North Alabama - Huntsville

Alaska

  • Alaska Urological Institute dba Alaska Clinical Research Center - Anchorage

Connecticut

  • Urology Associates of Norwalk - Norwalk

Georgia

  • Atlanta Medical Research Institute - Alpharetta

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2013-10-28
Est. Completion 2017-01-05
Phase Phase 4

Sponsor

Allergan

314 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01945489

The ClinicalTrials.gov registry entry for NCT01945489 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 206-participant average among 45 other Overactive Bladder trials with a reported enrollment target (23% higher). The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.

NCT01945489 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Indiana, California.

Frequently Asked Questions

What is clinical trial NCT01945489 about?

NCT01945489 is a clinical study titled "OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder". This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

What is the current status of trial NCT01945489?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 254 participants. The study started on 2013-10-28. Estimated completion is 2017-01-05.

What conditions does trial NCT01945489 study?

This clinical trial studies the following conditions: Overactive Bladder.

What interventions are being tested in trial NCT01945489?

The interventions under investigation include: Normal saline (DRUG), onabotulinumtoxinA (BIOLOGICAL).

Who is sponsoring clinical trial NCT01945489?

This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01945489 being conducted?

This trial has 20 study locations across Alabama, Alaska, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.