Study of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
NCT ID: NCT05141006
Last Updated: 2025-05-06
Study Results
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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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2022-03-29
2024-12-06
Brief Summary
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BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 80 female participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in approximately 40 sites in the United States and Canada.
Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period 2.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BOTOX
Participants will receive BOTOX on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.
BOTOX
Injection into the bladder
Placebo
Participants will receive placebo on Day 1 and will be followed for at least 12 weeks in treatment period 1. An optional dose of BOTOX in Treatment 2 can be requested between Weeks 12 and 24.
BOTOX
Injection into the bladder
Placebo for BOTOX
Injection into the bladder
Interventions
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BOTOX
Injection into the bladder
Placebo for BOTOX
Injection into the bladder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Urology Centers of Alabama /ID# 243600
Homewood, Alabama, United States
Urology Associates of Mobile, PA /ID# 255854
Mobile, Alabama, United States
Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002
Mobile, Alabama, United States
Sun Kim Urology /ID# 257566
Buena Park, California, United States
Cedars-Sinai Medical Center /ID# 245786
Los Angeles, California, United States
University of California, Los Angeles /ID# 245131
Los Angeles, California, United States
Tri Valley Urology Medical Group /ID# 254918
Murrieta, California, United States
Inland Urology /ID# 255410
Pomona, California, United States
UCSD Medical Center /ID# 244935
San Diego, California, United States
Prestige Medical Group /ID# 257564
Santa Ana, California, United States
Hartford Healthcare Group - Farmington /ID# 241037
Farmington, Connecticut, United States
Medstar Health Research Institute /ID# 245371
Washington D.C., District of Columbia, United States
Manatee Medical Research Institute /ID# 243859
Bradenton, Florida, United States
Clinical Research Center FL /ID# 243961
Pompano Beach, Florida, United States
Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034
Shreveport, Louisiana, United States
Bay State Clincial Trials, Inc /ID# 240848
Watertown, Massachusetts, United States
Sheldon Freedman MD, ltd /ID# 241003
Las Vegas, Nevada, United States
Western New York Urology Associates - Harlem Professional Park /ID# 241036
Cheektowaga, New York, United States
North Shore University Hospital /ID# 242594
New Hyde Park, New York, United States
NYU Langone Medical Center /ID# 241090
New York, New York, United States
Columbia University Medical Center /ID# 241086
New York, New York, United States
Columbia University Medical Center /ID# 241087
New York, New York, United States
Crystal Run Healthcare - Warwick /ID# 241116
Warwick, New York, United States
Cleveland Clinic Avon Hospital /ID# 247221
Avon, Ohio, United States
The Christ Hospital /ID# 244800
Cincinnati, Ohio, United States
Univ Hosp Cleveland /ID# 247228
Cleveland, Ohio, United States
MetroHealth Medical Center /ID# 254812
Cleveland, Ohio, United States
Wright State Physicians Obstetrics and Gynecology /ID# 241112
Oakwood, Ohio, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012
Allentown, Pennsylvania, United States
MidLantic Urology /ID# 240997
Bala-Cynwyd, Pennsylvania, United States
Thomas Jefferson University Hospital /ID# 243703
Philadelphia, Pennsylvania, United States
Medical University of South Carolina /ID# 242780
Charleston, South Carolina, United States
Southern Shores Urogynecology /ID# 253316
Myrtle Beach, South Carolina, United States
Chattanooga Research and Medicine /ID# 241092
Chattanooga, Tennessee, United States
Urology Associates PC - Nashville /ID# 242914
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center /ID# 244931
Dallas, Texas, United States
Advances in Health, Inc. /ID# 240850
Pearland, Texas, United States
Potomac Urology - Alexandria /ID# 243963
Alexandria, Virginia, United States
Specialists For Women - Hillpoint /ID# 242541
Suffolk, Virginia, United States
Urology of Virginia /ID# 240843
Virginia Beach, Virginia, United States
Queen's University /ID# 243972
Kingston, Ontario, Canada
Sunnybrook Health Sciences Ctr /ID# 243243
Toronto, Ontario, Canada
CHUS - Hopital Fleurimont /ID# 244058
Sherbrooke, Quebec, Canada
Countries
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Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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M21-459
Identifier Type: -
Identifier Source: org_study_id
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