A Safety and Efficacy Study of LiRIS® in Females With Int... | NCT02395042 | Trialant
NCT02395042
Sponsor
Allergan
Status
Completed
Last Update Posted
Oct 5, 2018Actual
Enrollment
59Actual
Phase
Phase 2
Conditions
Cystitis, Interstitial
Ulcer
Interventions
LiRIS®
LiRIS Placebo
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT02395042
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
201025-001
Secondary IDs
Not provided
Brief Title
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's Lesions
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 15, 2015Actual
Primary Completion Date
Jun 29, 2017Actual
Completion Date
Nov 20, 2017Actual
First Submitted Date
Mar 17, 2015
First Submission Date that Met QC Criteria
Mar 17, 2015
First Posted Date
Mar 20, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 29, 2018
Results First Submitted that Met QC Criteria
Sep 5, 2018
Results First Posted Date
Oct 5, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 5, 2018
Last Update Posted Date
Oct 5, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.
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.
Drug: LiRIS®
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.
Drug: LiRIS®
Drug: LiRIS Placebo
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.
Drug: LiRIS®
Drug: LiRIS Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LiRIS®
Drug
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline (Day -7 to Day 0) to Week 4
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Evans R, Kohan A, Moldwin R, Radecki D, Geib T, Peters KM. Safety, tolerability, and efficacy of LiRIS 400 mg in women with interstitial cystitis/bladder pain syndrome with or without Hunner lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739. doi: 10.1002/nau.24702. Epub 2021 Jul 20.
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.
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
LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Baseline (Day 0) to Week 4
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.
Baseline (Day 1) to Week 4
Vacaville
California
95688
United States
Women's Health Specialty Care
Farmington
Connecticut
06032
United States
Atlanta Medical Research Institute
Alpharetta
Georgia
30005
United States
Anne Arundel Urology, P.A.
Annapolis
Maryland
21401
United States
Chesapeake Urology Research Associates
Baltimore
Maryland
21237
United States
Beyer Research
Kalamazoo
Michigan
49009
United States
Beaumont Health System
Royal Oak
Michigan
48073
United States
Washington University School of Medicine Department of Surgery
St Louis
Missouri
63110
United States
Western New York Urology Associates, LLC
Cheektowaga
New York
14214
United States
McKay Urology
Charlotte
North Carolina
28207
United States
Eastern Urological Associates, PA
Greenville
North Carolina
27834
United States
Wake Forest Baptist Health
Winston-Salem
North Carolina
27103
United States
MetroHealth System/Center for Advanced Gynecology
Cleveland
Ohio
44109
United States
Philadelphia Urosurgical Associates
Philadelphia
Pennsylvania
19107
United States
University of Washington
Seattle
Washington
98195
United States
Aurora Health Care
West Allis
Wisconsin
53227
United States
Silverado Research Inc
Victoria
British Columbia
V8T 2C1
Canada
Sunnybrook Health Science Centre
Toronto
Ontario
M4N 3M5
Canada
FG001
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.
FG002
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.
FG00012 subjects
FG00131 subjects
FG00216 subjects
COMPLETED
FG0009 subjects
FG00125 subjects
FG00214 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0022 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0013 subjects
FG0021 subjects
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
Other Miscellaneous Reasons
FG0000 subjects
FG0012 subjects
FG0021 subjects
Treatment 2 Period
Type
Comment
Milestone Data
STARTED
FG00010 subjectsNot all participants participated in Treatment 2 Period.
FG00124 subjectsNot all participants participated in Treatment 2 Period.
FG00213 subjectsNot all participants participated in Treatment 2 Period.
COMPLETED
FG0009 subjects
FG00123 subjects
FG00213 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
Modified Intent-to-treat (mITT) Population included all randomized participants who had the investigational product inserted.
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.
BG001
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.
BG002
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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00131
BG00216
BG00359
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00131
ParticipantsBG00216
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00131
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Caucasian
ParticipantsBG00012
ParticipantsBG00131
ParticipantsBG002
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.
Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with available baseline data.
Mean
Full Range
score on a scale
Title
Denominators
Categories
ParticipantsBG00011
ParticipantsBG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.
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.
OG001
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.
OG002
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.
Units
Counts
Participants
OG0009
OG00126
OG00210
Title
Denominators
Categories
Title
Measurements
OG000-1.6(-2.68 to -0.45)
OG001-2.7(-3.36 to -2.06)
OG002-2.5(-3.53 to -1.44)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
0.142
Least Squares Mean Difference
-1.15
Superiority
OG000
OG002
ANCOVA
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.
Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.
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.
OG001
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.
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.
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.
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.
OG001
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.
Time Frame
Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days
Description
Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of >=5% for the preferred term.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
LiRIS Placebo, LiRIS Placebo (Tx 1)
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. Adverse events (AEs) reported in Tx 1.
0
12
1
12
9
12
EG001
LiRIS®, LiRIS® (Tx 1)
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. AEs reported in Tx 1.
0
31
0
31
21
31
EG002
LiRIS Placebo, LiRIS® (Tx 1)
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. AEs reported in Tx 1.
0
16
0
16
10
16
EG003
LiRIS Placebo, LiRIS Placebo/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. AEs reported in Tx 2.
0
10
0
10
4
10
EG004
LiRIS®, LiRIS® /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. AEs reported in Tx 2.
0
24
0
24
2
24
EG005
LiRIS Placebo, LiRIS /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. AEs reported in Tx 2.
0
13
0
13
3
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Urosepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG0030 affected10 at risk
EG0040 affected24 at risk
EG0050 affected13 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
EG0030 affected10 at risk
EG0040 affected24 at risk
EG0050 affected13 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Medical device pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0012 affected31 at risk
EG0021 affected16 at risk
EG003
Suprapubic pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
EG003
Medical device discomfort
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
EG003
Thirst
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0015 affected31 at risk
EG0022 affected16 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0005 affected12 at risk
EG0016 affected31 at risk
EG0023 affected16 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0013 affected31 at risk
EG0023 affected16 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0014 affected31 at risk
EG0022 affected16 at risk
EG003
Bladder discomfort
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0014 affected31 at risk
EG0020 affected16 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Urethral pain
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0022 affected16 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Liver function test increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
59
Title
Measurements
BG00053.58± 12.09
BG00157.65± 12.76
BG00257.31± 14.25
BG00356.73± 12.93
16
ParticipantsBG00359
Title
Measurements
Female
BG00012
BG00131
BG00216
BG00359
Male
BG0000
BG0010
BG0020
BG0030
16
ParticipantsBG00359
Title
Measurements
BG0008
BG00129
BG00216
BG00353
Black
ParticipantsBG00012
ParticipantsBG00131
ParticipantsBG00216
ParticipantsBG00359
Title
Measurements
BG0003
BG0011
BG0020
BG003
Asian
ParticipantsBG00012
ParticipantsBG00131
ParticipantsBG00216
ParticipantsBG00359
Title
Measurements
BG0000
BG0011
BG0020
BG003
Hispanic
ParticipantsBG00012
ParticipantsBG00131
ParticipantsBG00216
ParticipantsBG00359
Title
Measurements
BG0001
BG0010
BG0020
BG003
28
ParticipantsBG00214
ParticipantsBG00353
Title
Measurements
BG0006.0(4.3 to 8.0)
BG0015.5(3.2 to 9.3)
BG0025.6(4.1 to 7.8)
BG0035.7(3.2 to 9.3)
ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
0.319
Least Squares Mean Difference
-0.92
Superiority
OG002
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.
Units
Counts
Participants
OG0008
OG00118
OG00212
Title
Denominators
Categories
Title
Measurements
OG0000.8(-0.04 to 1.7)
OG001-0.6(-1.21 to -0.05)
OG002-0.2(-0.87 to 0.50)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
0.024
Least Squares Mean Difference
-1.46
Superiority
OG000
OG002
ANCOVA
ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
0.137
Least Squares Mean Difference
-1.02
Superiority
OG002
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.