Phase 2
N=131
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
Cystitis, Interstitial · Painful Bladder Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02411110 ↗Enrolled (actual)
131
Serious AEs
1.8%
Results posted
Jan 2018
Primary outcome: Primary: Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up — -1.2; -1.5 score on a scale — p=0.505
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LiRIS® (Combination_product); LiRIS Placebo (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up |
-1.2; -1.5 | 0.505 |
Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
Eligibility Criteria
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®
Data sourced from ClinicalTrials.gov (NCT02411110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.