Trial Outcomes & Findings for A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome (NCT NCT02411110)
NCT ID: NCT02411110
Last Updated: 2018-01-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
Baseline (Days -7 to 0) to Treatment 1 Week 4
Results posted on
2018-01-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
65
|
66
|
|
Treatment Period 1
COMPLETED
|
56
|
59
|
|
Treatment Period 1
NOT COMPLETED
|
9
|
7
|
|
Treatment Period 2
STARTED
|
50
|
48
|
|
Treatment Period 2
COMPLETED
|
49
|
44
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Treatment Period 1
Adverse Event
|
4
|
2
|
|
Treatment Period 1
Lost to Follow-up
|
1
|
0
|
|
Treatment Period 1
Personal Reasons
|
2
|
5
|
|
Treatment Period 1
Other Miscellaneous Reasons
|
2
|
0
|
|
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
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
Baseline characteristics by cohort
| Measure |
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
n=65 Participants
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.
|
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
n=66 Participants
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.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.58 years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
44.20 years
STANDARD_DEVIATION 12.65 • n=7 Participants
|
46.37 years
STANDARD_DEVIATION 13.73 • n=5 Participants
|
|
Age, Customized
< 40 Years
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Age, Customized
≥ 40 Years
|
40 participants
n=5 Participants
|
42 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Days -7 to 0) to Treatment 1 Week 4Population: Modified Intent-to-Treat (mITT) Analysis Population included all participants who were randomized and received Treatment 1.
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.
Outcome measures
| Measure |
LiRIS® (Treatment Period 1)
n=65 Participants
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.
|
LiRIS Placebo (Treatment Period 1)
n=66 Participants
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.
|
|---|---|---|
|
Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
|
-1.2 score on a scale
Interval -1.77 to -0.58
|
-1.5 score on a scale
Interval -2.14 to -0.87
|
Adverse Events
LiRIS Placebo (Treatment Period 1)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
LiRIS® (Treatment Period 1)
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LiRIS Placebo (Treatment Period 1)
n=66 participants at risk
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.
|
LiRIS® (Treatment Period 1)
n=65 participants at risk
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.
|
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
n=48 participants at risk
Participants who received Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
|
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
n=50 participants at risk
Participants who received LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
|
|---|---|---|---|---|
|
Infections and infestations
Kidney infection
|
0.00%
0/66
|
1.5%
1/65
|
0.00%
0/48
|
0.00%
0/50
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/66
|
1.5%
1/65
|
0.00%
0/48
|
0.00%
0/50
|
|
Reproductive system and breast disorders
Pelvic congestion
|
0.00%
0/66
|
1.5%
1/65
|
0.00%
0/48
|
0.00%
0/50
|
|
Infections and infestations
Pneumonia
|
1.5%
1/66
|
0.00%
0/65
|
0.00%
0/48
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/66
|
1.5%
1/65
|
0.00%
0/48
|
0.00%
0/50
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66
|
0.00%
0/65
|
2.1%
1/48
|
0.00%
0/50
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/66
|
0.00%
0/65
|
2.1%
1/48
|
0.00%
0/50
|
Other adverse events
| Measure |
LiRIS Placebo (Treatment Period 1)
n=66 participants at risk
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.
|
LiRIS® (Treatment Period 1)
n=65 participants at risk
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.
|
LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
n=48 participants at risk
Participants who received Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
|
LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
n=50 participants at risk
Participants who received LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66
|
6.2%
4/65
|
4.2%
2/48
|
4.0%
2/50
|
|
Infections and infestations
Urinary tract infection
|
24.2%
16/66
|
15.4%
10/65
|
8.3%
4/48
|
8.0%
4/50
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.1%
4/66
|
4.6%
3/65
|
0.00%
0/48
|
4.0%
2/50
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.0%
2/66
|
9.2%
6/65
|
4.2%
2/48
|
0.00%
0/50
|
|
Renal and urinary disorders
Dysuria
|
16.7%
11/66
|
20.0%
13/65
|
0.00%
0/48
|
4.0%
2/50
|
|
Renal and urinary disorders
Urethral pain
|
6.1%
4/66
|
9.2%
6/65
|
6.2%
3/48
|
4.0%
2/50
|
|
Renal and urinary disorders
Bladder pain
|
7.6%
5/66
|
6.2%
4/65
|
2.1%
1/48
|
2.0%
1/50
|
|
Renal and urinary disorders
Haematuria
|
9.1%
6/66
|
3.1%
2/65
|
2.1%
1/48
|
2.0%
1/50
|
|
Renal and urinary disorders
Bladder discomfort
|
1.5%
1/66
|
7.7%
5/65
|
2.1%
1/48
|
2.0%
1/50
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
1/66
|
1.5%
1/65
|
0.00%
0/48
|
6.0%
3/50
|
|
Renal and urinary disorders
Micturition urgency
|
1.5%
1/66
|
1.5%
1/65
|
0.00%
0/48
|
6.0%
3/50
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/66
|
1.5%
1/65
|
0.00%
0/48
|
6.0%
3/50
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER