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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02411110 | A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome | PHASE2 | COMPLETED | 131 | — | — | May 21, 2015 | Jan 9, 2017 | Jan 4, 2018 | 34 | United States, Canada |
| NCT02395042 | A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions | PHASE2 | COMPLETED | 59 | — | — | Apr 15, 2015 | Nov 20, 2017 | Oct 5, 2018 | 19 | United States, Canada |
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.
The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores 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 (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.
| Arm | Type | Description |
|---|---|---|
| LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | EXPERIMENTAL | Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | OTHER | Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) | PLACEBO_COMPARATOR | Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. |
| LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) | EXPERIMENTAL | Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. |
| LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) | EXPERIMENTAL | Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. |
| Name | Type | Description |
|---|---|---|
| LiRIS® | COMBINATION_PRODUCT | LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy. |
| LiRIS Placebo | COMBINATION_PRODUCT | LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy. |
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®