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)

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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)

Brief description of study

The objectives of the study are to demonstrate the safety and efficacy of BOTOX 100 U in reducing bladder pain compared to placebo in adult female subjects with IC/BPS. The primary endpoint is the change from baseline to Week 6 in the average daily worst bladder pain on the 11-point (0-10) Numeric Rating Scale (NRS).

Clinical Study Identifier: s22-00322

ClinicalTrials.gov Identifier: NCT05141006

Clinical Research Studies

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)

Brief description of study

Recruitment Status

212-263-4432

646-754-7432