Summary

Eligibility
for females ages 18-75 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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 Unites States. Participants will receive BOTOX or placebo injected into the bladder on Day 1 and followed for at least 12 weeks in treatment 1. Eligible participants may request additional dose of BOTOX between Weeks 12 and 24 and 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.

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)

Keywords

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) BOTOX Botulinum Toxin Type A OnabotulinumtoxinA Cystitis Cystitis, Interstitial Syndrome Somatoform Disorders Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA

Eligibility

You can join if…

Open to females ages 18-75

  • 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.

You CAN'T join if...

  • History or current diagnosis of Hunner Lesions.

Locations

  • UCSD Medical Center /ID# 244935 not yet accepting patients
    San Diego California 92103-8620 United States
  • University of California, Los Angeles /ID# 245131 not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Allergan
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT05141006
Phase
Phase 2 Interstitial Cystitis Research Study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated