Phase 2
N=59
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
Cystitis, Interstitial · Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT02395042 ↗Enrolled (actual)
59
Serious AEs
0.9%
Results posted
Oct 2018
Primary outcome: Primary: Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) — -1.6; -2.7; -2.5 score on a scale — p=0.142
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LiRIS® (Drug); LiRIS Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) |
-1.6; -2.7; -2.5 | 0.142 |
| SECONDARY Change From Baseline in the Number of Hunner's Lesions |
0.8; -0.6; -0.2 | 0.024 sig |
| SECONDARY Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions |
— | — |
Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
Exclusion Criteria
- Previous treatment with LiRIS®
- Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Data sourced from ClinicalTrials.gov (NCT02395042). 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.