Back to resultsStudy of BOTOX Injections to Assess Change in Disease Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Primary Purpose
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BOTOX
Placebo for BOTOX
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) focused on measuring Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), BOTOX, Botulinum Toxin Type A, OnabotulinumtoxinA
Eligibility Criteria
Inclusion Criteria:
- Presence of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms for at least 6 months, diagnosed by the investigator as IC/BPS and confirmed dominant bladder derived pain.
Exclusion Criteria:
- History or current diagnosis of Hunner Lesions.
Sites / Locations
- Urology Centers of Alabama /ID# 243600Recruiting
- Urology Associates of Mobile, PA /ID# 255854Recruiting
- Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002
- University of California, Los Angeles /ID# 245131Recruiting
- Inland Urology /ID# 255410Recruiting
- UCSD Medical Center /ID# 244935Recruiting
- Prestige Medical Group /ID# 257564Recruiting
- Cedars-Sinai Medical Center-West Hollywood /ID# 245786Recruiting
- Women's Health Connecticut, Inc - Women's Health Specialty Care - Farmington /ID# 241037Recruiting
- Medstar Health Research Institute /ID# 245371Recruiting
- Manatee Medical Research Institute /ID# 243859Recruiting
- Clinical Research Center FL /ID# 243961Recruiting
- Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034Recruiting
- Bay State Clincial Trials, Inc /ID# 240848Recruiting
- Sheldon Freedman MD, ltd /ID# 241003Recruiting
- Western New York Urology Associates - Harlem Professional Park /ID# 241036
- North Shore University Hospital /ID# 242594Recruiting
- New York University, Langone Health /ID# 241090Recruiting
- Columbia University Medical Center /ID# 241086Recruiting
- Columbia University Medical Center /ID# 241087Recruiting
- Crystal Run Healthcare - Warwick /ID# 241116Recruiting
- The Christ Hospital /ID# 244800Recruiting
- Univ Hosp Cleveland /ID# 247228Recruiting
- Wright State Physicians Obstetrics and Gynecology /ID# 241112Recruiting
- The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012Recruiting
- MidLantic Urology /ID# 240997Recruiting
- Thomas Jefferson University /ID# 243703Recruiting
- Chattanooga Medical Research /ID# 241092Recruiting
- Urology Associates PC - Nashville /ID# 242914Recruiting
- University of Texas Southwestern Medical Center /ID# 244931Recruiting
- Advances in Health, Inc. /ID# 240850Recruiting
- Potomac Urology - Alexandria /ID# 243963
- Specialists For Women - Hillpoint /ID# 242541
- Urology of Virginia /ID# 240843
- Sunnybrook Health Sciences Ctr /ID# 243243Recruiting
- CHUS - Hopital Fleurimont /ID# 244058Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BOTOX
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Average Daily Worst Bladder Pain
Daily worst bladder pain will be assessed on the 11-point (0-10) numeric rating scale where 0 = no pain and 10 = the worst pain possible.
Secondary Outcome Measures
Change in the Average Number of Micturition Episodes per 24-hour Period
Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary.
Change in the Average Number of Urgency Episodes per 24-hour Period
Urgency episodes will be reported in the 3-day bladder diary.
Change in the Average Number of Nocturia Episodes per 24-hour Period
Nocturia episodes will be reported in the 3-day bladder diary.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05141006
Brief Title
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)
Official Title
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX, Followed by an Optional Open-Label Treatment With BOTOX, in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
January 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse events and change in disease symptoms will be evaluated.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Keywords
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), BOTOX, Botulinum Toxin Type A, OnabotulinumtoxinA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BOTOX
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BOTOX
Other Intervention Name(s)
OnabotulinumtoxinA, Botulinum Toxin Type A
Intervention Description
Injection into the bladder
Intervention Type
Drug
Intervention Name(s)
Placebo for BOTOX
Intervention Description
Injection into the bladder
Primary Outcome Measure Information:
Title
Change in Average Daily Worst Bladder Pain
Description
Daily worst bladder pain will be assessed on the 11-point (0-10) numeric rating scale where 0 = no pain and 10 = the worst pain possible.
Time Frame
Baseline (Week 0) to Week 6
Secondary Outcome Measure Information:
Title
Change in the Average Number of Micturition Episodes per 24-hour Period
Description
Micturition (whether participant was able to urinate) episodes will be collected on the 3-day bladder diary.
Time Frame
Baseline (Week 0) to Week 6
Title
Change in the Average Number of Urgency Episodes per 24-hour Period
Description
Urgency episodes will be reported in the 3-day bladder diary.
Time Frame
Baseline (Week 0) to Week 6
Title
Change in the Average Number of Nocturia Episodes per 24-hour Period
Description
Nocturia episodes will be reported in the 3-day bladder diary.
Time Frame
Baseline (Week 0) to Week 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Presence of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) symptoms for at least 6 months, diagnosed by the investigator as IC/BPS, and confirmed dominant bladder derived pain.
Exclusion Criteria:
- History or current diagnosis of Hunner Lesions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama /ID# 243600
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology Associates of Mobile, PA /ID# 255854
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-6705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
251-234-5933
Facility Name
Alliance for Multispecialty Research (AMR) - Mobile /ID# 241002
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Completed
Facility Name
University of California, Los Angeles /ID# 245131
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Inland Urology /ID# 255410
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSD Medical Center /ID# 244935
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8620
Country
United States
Individual Site Status
Recruiting
Facility Name
Prestige Medical Group /ID# 257564
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars-Sinai Medical Center-West Hollywood /ID# 245786
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Women's Health Connecticut, Inc - Women's Health Specialty Care - Farmington /ID# 241037
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032-1943
Country
United States
Individual Site Status
Recruiting
Facility Name
Medstar Health Research Institute /ID# 245371
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Manatee Medical Research Institute /ID# 243859
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205-8626
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Center FL /ID# 243961
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner LSU Health Shreveport - Regional Urology. /ID# 241034
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Individual Site Status
Recruiting
Facility Name
Bay State Clincial Trials, Inc /ID# 240848
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Individual Site Status
Recruiting
Facility Name
Sheldon Freedman MD, ltd /ID# 241003
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Name
Western New York Urology Associates - Harlem Professional Park /ID# 241036
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225-2591
Country
United States
Individual Site Status
Completed
Facility Name
North Shore University Hospital /ID# 242594
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University, Langone Health /ID# 241090
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center /ID# 241086
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center /ID# 241087
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Individual Site Status
Recruiting
Facility Name
Crystal Run Healthcare - Warwick /ID# 241116
City
Warwick
State/Province
New York
ZIP/Postal Code
10990-4105
Country
United States
Individual Site Status
Recruiting
Facility Name
The Christ Hospital /ID# 244800
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ Hosp Cleveland /ID# 247228
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Wright State Physicians Obstetrics and Gynecology /ID# 241112
City
Oakwood
State/Province
Ohio
ZIP/Postal Code
45409-1980
Country
United States
Individual Site Status
Recruiting
Facility Name
The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown /ID# 241012
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103-3691
Country
United States
Individual Site Status
Recruiting
Facility Name
MidLantic Urology /ID# 240997
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University /ID# 243703
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4414
Country
United States
Individual Site Status
Recruiting
Facility Name
Chattanooga Medical Research /ID# 241092
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
Urology Associates PC - Nashville /ID# 242914
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209-4035
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center /ID# 244931
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Individual Site Status
Recruiting
Facility Name
Advances in Health, Inc. /ID# 240850
City
Pearland
State/Province
Texas
ZIP/Postal Code
77854
Country
United States
Individual Site Status
Recruiting
Facility Name
Potomac Urology - Alexandria /ID# 243963
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311-1735
Country
United States
Individual Site Status
Completed
Facility Name
Specialists For Women - Hillpoint /ID# 242541
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23434-7181
Country
United States
Individual Site Status
Completed
Facility Name
Urology of Virginia /ID# 240843
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Completed
Facility Name
Sunnybrook Health Sciences Ctr /ID# 243243
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHUS - Hopital Fleurimont /ID# 244058
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
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)
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