Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01150565 | Safety Study of LiRIS in Interstitial Cystitis (IC) Patients | PHASE1 | COMPLETED | 18 | — | — | Jul 1, 2010 | Sep 1, 2011 | Nov 25, 2014 | 3 | Canada |
| Arm | Type | Description |
|---|---|---|
| LiRIS low dose | EXPERIMENTAL | The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14. |
| LiRIS high dose | EXPERIMENTAL | The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14. |
| Name | Type | Description |
|---|---|---|
| LiRIS low dose and LiRIS high dose | DRUG | Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period. |
Inclusion Criteria: * Female patients ≥ 18 years of age * If of child-bearing potential, agrees to use effective contraception defined by protocol * Capable of understanding and completing symptom diaries and questionnaires as required in the study * Diagnosed with IC, as defined by protocol criter...