Phase 1
Completed N=10
A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
Chronic Interstitial Cystitis
Source: ClinicalTrials.gov NCT01879683 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 — 0.0; 85.7; 14.3; 0.0 percentage of participants
Summary
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14 |
0.0; 85.7; 14.3; 0.0 | — |
| PRIMARY Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28 |
0.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain |
5.46; -1.71; -2.97; -4.00; -4.27; -4.11 | — |
| SECONDARY Change From Baseline in Patient Reported IC Symptom: Daily Total Voids |
18.2; -3.3; -3.5; -5.7; -5.5; -5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Women age 18 and older
- Interstitial Cystitis with history of Hunner's lesions in the bladder
- Moderate to severe bladder discomfort
- Confirmation of Hunner's lesions in Bladder
- Able to report symptom (pain and voiding frequency) in a diary throughout the study
Exclusion Criteria
- Pregnant women
- History or presence of bladder cancer
- History or presence of any condition that would make it difficult to evaluate bladder symptoms
Data sourced from ClinicalTrials.gov (NCT01879683). 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. Informational only — not medical advice.