Cystitis, Interstitial, Painful Bladder Syndrome
Conditions
Brief summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.
Interventions
COMBINATION_PRODUCTLiRIS®
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.
COMBINATION_PRODUCTLiRIS 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 or bladder pain syndrome
Exclusion criteria
* Diagnosis of interstitial cystitis with Hunner's lesions/ulcers * Previous treatment with LiRIS®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | Baseline (Days -7 to 0) to Treatment 1 Week 4 | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. | 65 |
| LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) 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 LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. | 66 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 1 | Adverse Event | 4 | 2 |
| Treatment Period 1 | Lost to Follow-up | 1 | 0 |
| Treatment Period 1 | Other Miscellaneous Reasons | 2 | 0 |
| Treatment Period 1 | Personal Reasons | 2 | 5 |
| Treatment Period 2 | Adverse Event | 1 | 0 |
| Treatment Period 2 | Lost to Follow-up | 0 | 2 |
| Treatment Period 2 | Personal Reasons | 0 | 2 |
Baseline characteristics
| Characteristic | LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | Total |
|---|---|---|---|
| Age, Continuous | 48.58 years STANDARD_DEVIATION 14.5 | 44.20 years STANDARD_DEVIATION 12.65 | 46.37 years STANDARD_DEVIATION 13.73 |
| Age, Customized < 40 Years | 25 participants | 24 participants | 49 participants |
| Age, Customized ≥ 40 Years | 40 participants | 42 participants | 82 participants |
| Sex: Female, Male Female | 65 Participants | 66 Participants | 131 Participants |
| Sex: Female, Male Male | 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 |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 22 / 66 | 22 / 65 | 4 / 48 | 7 / 50 |
| serious Total, serious adverse events | 1 / 66 | 2 / 65 | 1 / 48 | 0 / 50 |
Outcome results
Primary
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
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.
Time frame: Baseline (Days -7 to 0) to Treatment 1 Week 4
Population: Modified Intent-to-Treat (mITT) Analysis Population included all participants who were randomized and received Treatment 1.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| LiRIS® (Treatment Period 1) | Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | -1.2 score on a scale |
| LiRIS Placebo (Treatment Period 1) | Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up | -1.5 score on a scale |
p-value: 0.505ANCOVA