Cystitis, Interstitial, Ulcer
Conditions
Brief summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.
Interventions
DRUGLiRIS®
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.
DRUGLiRIS Placebo
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
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) | Baseline (Day -7 to Day 0) to Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Number of Hunner's Lesions | Baseline (Day 0) to Week 4 | During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An 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. |
| Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions | Baseline (Day 1) to Week 4 | A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) Treatment 1 Period: 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: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. | 12 |
| LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) 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. | 31 |
| LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) 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. | 16 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment 1 Period | Adverse Event | 1 | 3 | 1 |
| Treatment 1 Period | Lack of Efficacy | 1 | 1 | 0 |
| Treatment 1 Period | Lost to Follow-up | 1 | 0 | 0 |
| Treatment 1 Period | Other Miscellaneous Reasons | 0 | 2 | 1 |
| Treatment 2 Period | Lack of Efficacy | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) | LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) | LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) | Total |
|---|---|---|---|---|
| Age, Continuous | 53.58 years STANDARD_DEVIATION 12.09 | 57.65 years STANDARD_DEVIATION 12.76 | 57.31 years STANDARD_DEVIATION 14.25 | 56.73 years STANDARD_DEVIATION 12.93 |
| Daily Average Bladder Pain Numeric Rating Scale (NRS) | 6.0 score on a scale | 5.5 score on a scale | 5.6 score on a scale | 5.7 score on a scale |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 8 Participants | 29 Participants | 16 Participants | 53 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 12 Participants | 31 Participants | 16 Participants | 59 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 31 | 0 / 16 | 0 / 10 | 0 / 24 | 0 / 13 |
| other Total, other adverse events | 9 / 12 | 21 / 31 | 10 / 16 | 4 / 10 | 2 / 24 | 3 / 13 |
| serious Total, serious adverse events | 1 / 12 | 0 / 31 | 0 / 16 | 0 / 10 | 0 / 24 | 0 / 13 |
Outcome results
Primary
Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
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.
Time frame: Baseline (Day -7 to Day 0) to Week 4
Population: Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) | Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) | -1.6 score on a scale |
| LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) | Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) | -2.7 score on a scale |
| LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) | Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) | -2.5 score on a scale |
p-value: 0.142ANCOVA
p-value: 0.319ANCOVA
Secondary
Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Week 4
Population: Data for the planned composite Hunner's Lesions score were supposed to be generated based on digital images by a software algorithm, but the system never worked and no data were generated.
Secondary
Change From Baseline in the Number of Hunner's Lesions
During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An 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.
Time frame: Baseline (Day 0) to Week 4
Population: Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) | Change From Baseline in the Number of Hunner's Lesions | 0.8 Hunner's lesions |
| LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) | Change From Baseline in the Number of Hunner's Lesions | -0.6 Hunner's lesions |
| LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) | Change From Baseline in the Number of Hunner's Lesions | -0.2 Hunner's lesions |
p-value: 0.024ANCOVA
p-value: 0.137ANCOVA