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)
Purpose
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.
Condition
- Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
Recruiting Locations
Homewood, Alabama 35209
New York, New York 10032-3729
Dallas, Texas 75390-7208
Nashville, Tennessee 37209-4035
Chattanooga, Tennessee 37412-3964
Myrtle Beach, South Carolina 29752
Charleston, South Carolina 29425
Philadelphia, Pennsylvania 19107-4414
Bala-Cynwyd, Pennsylvania 19004
Allentown, Pennsylvania 18103-3691
Oakwood, Ohio 45409-1980
Cleveland, Ohio 44109
Cleveland, Ohio 44106
Cincinnati, Ohio 45219
Avon, Ohio 44011-1172
Warwick, New York 10990-4105
New York, New York 10032-3729
Mobile, Alabama 36608-6705
Site Coordinator
251-234-5933
Santa Ana, California 92705
Buena Park, California 90621
Los Angeles, California 90048
Los Angeles, California 90095
Murrieta, California 92562-4902
Pomona, California 91767
San Diego, California 92103-8620
Farmington, Connecticut 06032-1943
New York, New York 10017
Washington, District of Columbia 20010
Bradenton, Florida 34205-8626
Pompano Beach, Florida 33060
Shreveport, Louisiana 71106
Watertown, Massachusetts 01890
Las Vegas, Nevada 89144
Pearland, Texas 77854
More Details
- NCT ID
- NCT05141006
- Status
- Recruiting
- Sponsor
- Allergan