A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome

Phase 2

Completed

• Conditions: Painful Bladder Syndrome; Cystitis, Interstitial

• Registration Number: NCT02411110
• Lead Sponsor: Allergan

Brief Summary

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-03
• Study First Posted: 2015-04-08
• Study Start: 2015-05-21
• Primary Completion: 2016-10-12
• Study Completion: 2017-01-09
• Status Verified: 2017-12
• Results First Submitted: 2017-12-06
• Results First Submitted QC: 2017-12-06
• Last Update Submitted: 2017-12-06
• Results First Posted: 2018-01-04
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

• Diagnosis of interstitial cystitis or bladder pain syndrome

Exclusion Criteria

• Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
• Previous treatment with LiRIS®

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up	Baseline (Days -7 to 0) to Treatment 1 Week 4	The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: \< 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors was used for analysis.

Trial Locations

Locations (34)

Coastal Clinical Research, Inc.; 🇺🇸 Mobile, Alabama, United States

IC Study LLC; 🇺🇸 Escondido, California, United States

Tower Urology; 🇺🇸 Los Angeles, California, United States

Tri Valley Urology Medical Group; 🇺🇸 Murrieta, California, United States

Genesis Research LLC; 🇺🇸 San Diego, California, United States

Sutter Health; 🇺🇸 Vacaville, California, United States

Women's Health Specialty Care; 🇺🇸 Farmington, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Manatee Medical Research Institute; 🇺🇸 Bradenton, Florida, United States

Atlanta Medical Research Instititute; 🇺🇸 Alpharetta, Georgia, United States

Scroll for more (24 remaining)