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BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence (APOLLO)

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ClinicalTrials.gov Identifier: NCT03320850
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Overactive Bladder With Urinary Incontinence Drug: OnabotulinumtoxinA and Hydrogel admixture Drug: Placebo and Hydrogel admixture Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-treatment, 2-stage, Dose-finding Study Evaluating the Efficacy and Safety of BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : January 4, 2020
Estimated Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 100U cohort - BOTOX® plus Hydrogel admixture
100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A

Placebo Comparator: 100U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation

Experimental: 300U cohort - BOTOX® plus Hydrogel admixture
300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A

Placebo Comparator: 300U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation

Experimental: 400U cohort - BOTOX® plus Hydrogel admixture
400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A

Placebo Comparator: 400U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation

Experimental: 500U cohort - BOTOX® plus Hydrogel admixture
500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: OnabotulinumtoxinA and Hydrogel admixture
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Other Names:
  • BOTOX®
  • Botulinum Toxin Type A

Placebo Comparator: 500U cohort - Placebo plus Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
Drug: Placebo and Hydrogel admixture
Placebo and Hydrogel admixture administered as a single intravesical instillation




Primary Outcome Measures :
  1. Change from baseline at Week 12 (Stage 2) in the average number of urinary incontinence episodes per day [ Time Frame: Baseline to Week 12 ]
    The participant records urinary incontinence in a 3-day bladder diary


Secondary Outcome Measures :
  1. Change from baseline at Week 12 (Stage 2) in the average number of micturition episodes per day [ Time Frame: Baseline to Week 12 ]
    The participant records the number of micturition episodes in a 3-day bladder diary

  2. Change from baseline at Week 12 (Stage 2) in the average volume voided per micturition [ Time Frame: Baseline to Week 12 ]
    Volume voided per micturition as recorded over one 24-hour period during the 3-day bladder diary


Other Outcome Measures:
  1. Duration of treatment effect through week 24 [ Time Frame: Baseline to Week 24 ]
    To be determined for all treatment responders with at least 50% reduction in the number of urinary incontinence episodes per day to the first date after week 6 with less than 50% reduction in urinary incontinence episodes per day



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
  • Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB

Exclusion Criteria:

  • Overactive Bladder caused by neurological condition
  • Patient has predominance of stress incontinence
  • History or evidence of pelvic or urological abnormality
  • Prior use of BOTOX for any urological condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320850


Contacts
Contact: Clinical Trials Registry Team 877‐277‐8566 IR-CTRegistration@allergan.com

  Hide Study Locations
Locations
United States, Arizona
Urological Assoc. of South AZ Recruiting
Tucson, Arizona, United States, 85715
United States, California
Tower Urology Recruiting
West Los Angeles, California, United States, 90048
United States, Connecticut
Women's Health Specialty Care Recruiting
Farmington, Connecticut, United States, 06032
CT Clinical Research Center/Urologist Specialist Recruiting
Middlebury, Connecticut, United States, 06762
United States, Florida
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States, 33060
United States, Idaho
Idaho Urologic Institute Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
North Shore University Health System Not yet recruiting
Skokie, Illinois, United States, 60076
United States, Indiana
First Urology,PSC Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Iowa
The Iowa Clinic Recruiting
West Des Moines, Iowa, United States, 50266
United States, Louisiana
Regional Urology, LLC Recruiting
Shreveport, Louisiana, United States, 71106
United States, Maryland
Chesapeake Urology Recruiting
Owings Mills, Maryland, United States, 21117
United States, Massachusetts
Bay State Clinical Trials, Inc. Recruiting
Watertown, Massachusetts, United States, 02472
United States, New Jersey
Urologic Research and Consulting LLC Not yet recruiting
Englewood, New Jersey, United States, 07631
United States, New York
Western New York Urology Associates Recruiting
Cheektowaga, New York, United States, 14225
AccuMed Research Associates Recruiting
Garden City, New York, United States, 11530
Manhattan Medical Research Practice PLLC Recruiting
New York, New York, United States, 10016
United States, Oregon
The Center for Men's & Women's Urology Recruiting
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Urologic Consultants of SE PA Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Virginia Urology Recruiting
Richmond, Virginia, United States, 23235
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
United States, Washington
Virginia Mason Medical Center Not yet recruiting
Seattle, Washington, United States, 98101
Multicare Allenmore Hospital Recruiting
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Allergan
Investigators
Study Director: Till Geib Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03320850     History of Changes
Other Study ID Numbers: 1839-201-021
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  • Phase II or III trials completed after 2008
  • Listed on clinicaltrials.gov or EudraCT
  • Have received regulatory approval in the United States and/or European Union (depending on registration plans) in a given indication
  • Primary manuscript(s) from the trial have been published

Access to data is contingent upon the following:

  • Researcher signs a data use agreement from Allergan
  • Data is to be used for non-commercial purposes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents