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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

October 23, 2017
October 25, 2017
March 13, 2018
October 4, 2017
January 4, 2020   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03320850 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Same as current
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
Same as current
 
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
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
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Urinary Incontinence
  • Overactive Bladder With Urinary Incontinence
  • Drug: OnabotulinumtoxinA and Hydrogel admixture
    BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
    Other Names:
    • BOTOX®
    • Botulinum Toxin Type A
  • Drug: Placebo and Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation
  • Experimental: 100U cohort - BOTOX® plus Hydrogel admixture
    100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: OnabotulinumtoxinA and Hydrogel admixture
  • Placebo Comparator: 100U cohort - Placebo plus Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: Placebo and Hydrogel admixture
  • Experimental: 300U cohort - BOTOX® plus Hydrogel admixture
    300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: OnabotulinumtoxinA and Hydrogel admixture
  • Placebo Comparator: 300U cohort - Placebo plus Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: Placebo and Hydrogel admixture
  • Experimental: 400U cohort - BOTOX® plus Hydrogel admixture
    400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: OnabotulinumtoxinA and Hydrogel admixture
  • Placebo Comparator: 400U cohort - Placebo plus Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: Placebo and Hydrogel admixture
  • Experimental: 500U cohort - BOTOX® plus Hydrogel admixture
    500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: OnabotulinumtoxinA and Hydrogel admixture
  • Placebo Comparator: 500U cohort - Placebo plus Hydrogel admixture
    Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
    Intervention: Drug: Placebo and Hydrogel admixture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
335
Same as current
March 3, 2020
January 4, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact: Clinical Trials Registry Team 877‐277‐8566 IR-CTRegistration@allergan.com
United States
 
 
NCT03320850
1839-201-021
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
Allergan
Allergan
Not Provided
Study Director: Till Geib Allergan
Allergan
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP