Double-Blind Placebo Controlled Study of Safety,Tolerabil... | NCT01475253

Status Module

Name	Class
TARIS Biomedical, Inc.	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine Releasing Intravesical System	Experimental	Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.	Drug: Lidocaine Releasing Intravesical System - LiRIS®
LiRIS containing inactive substance only	Placebo Comparator	LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.	Other: LiRIS Placebo
Cystoscopy Procedure	Sham Comparator	No intervention. Cystoscopy procedure is performed on study Day 0 and study Day 14 to mimick active and placebo study arms without insertion of Investigational Product into the bladder.	Procedure: Sham Cystoscopy Procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine Releasing Intravesical System - LiRIS®	Drug	Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7	Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.	Baseline, Day 7
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14	Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.	Baseline, Day 14
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28	Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.	Baseline, Day 28
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42	Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Responders Using the Global Response Assessment (GRA)	Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.	Baseline, Days 7, 14, 28 and 42

Eligibility Module

Name	Affiliation	Role
Curtis Nickel, MD	Queen's University/Kingston General Hospital/Ontario Canada	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials of Arizona		Glendale	Arizona	85306	United States
Citrus Valley Medical Research, Inc

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LiRIS® 400 mg - Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Secondary

Percentage of Responders Using the Global Response Assessment (GRA)

Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.

Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Posted

Number

Percentage of Responders

Baseline, Days 7, 14, 28 and 42

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Units	Counts
Participants	OG00042 OG00140

Title

Denominators

Categories

Day 7

Title	Measurements
	OG00024 OG00118

Day 14

Title	Measurements
	OG000

Primary

Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7

Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Posted

Mean

Standard Deviation

centimeters

Baseline, Day 7

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Primary

Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14

Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.

Posted

Mean

Standard Deviation

centimeters

Baseline, Day 14

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Primary

Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28

Posted

Mean

Standard Deviation

centimeters

Baseline, Day 28

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Primary

Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42

Posted

Mean

Standard Deviation

centimeters

Baseline, Day 42

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Secondary

Change From Baseline in Urinary Urgency as Assessed by VAS

Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words "No Urgency" (best) at the left end (0 cm) and the words "Urgency as bad as you can imagine" (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.

Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Posted

Mean

Standard Deviation

centimeters

Baseline, Days 7, 14, 28 and 42

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Secondary

Change From Baseline in Voiding Frequency

Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.

Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Posted

Mean

Standard Deviation

Voids

Baseline, Days 7, 14, 28 and 42

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Units	Counts

Secondary

Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score

Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement

Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Days 7, 14, 28 and 42

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Secondary

Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score

Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.

Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Days 7, 14, 28 and 42

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Secondary

Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings

Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.

Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.

Posted

Number

percentage of participants

Baseline, Day 14

ID	Title	Description
OG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
OG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LiRIS® 400 mg - Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	1	46	23	46
EG001	LiRIS® Placebo - Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.	2	46	23	46
EG002	Sham Cystoscopic Procedure - Randomized Study	Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.	0	11	7	11
EG003	LiRIS 400 mg - Open Label Extension	LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open lable extension.	0	56	29	56

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Dysuria	Renal and urinary disorders	MedDRA version 14	Systematic Assessment		EG00013 events11 affected46 at risk EG0018 events7 affected46 at risk EG0020 events0 affected11 at risk EG00312 events9 affected56 at risk
Bladder Pain	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0009 events8 affected46 at risk EG00112 events11 affected46 at risk EG0021 events1 affected11 at risk EG003
Bladder Discomfort	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0005 events5 affected46 at risk EG0012 events2 affected46 at risk EG0020 events0 affected11 at risk EG003
Hematuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0007 events7 affected46 at risk EG0012 events2 affected46 at risk EG0021 events1 affected11 at risk EG003
Urethral Pain	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0005 events4 affected46 at risk EG0015 events3 affected46 at risk EG0020 events0 affected11 at risk EG003
Urinary Tract Infection	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0004 events4 affected46 at risk EG0012 events2 affected46 at risk EG0021 events1 affected11 at risk EG003
Micturition Urgency	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0004 events3 affected46 at risk EG0014 events4 affected46 at risk EG0020 events0 affected11 at risk EG003
Bladder Irritation	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected46 at risk EG0010 events0 affected46 at risk EG0020 events0 affected11 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected46 at risk EG0011 events1 affected46 at risk EG0020 events0 affected11 at risk EG003
Headache	General disorders	MedDRA 14.0	Systematic Assessment		EG0003 events3 affected46 at risk EG0015 events3 affected46 at risk EG0020 events0 affected11 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected46 at risk EG0014 events3 affected46 at risk EG0020 events0 affected11 at risk EG003
Abdominal Pain (Lower)	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0002 events2 affected46 at risk EG0013 events3 affected46 at risk EG0020 events0 affected11 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected46 at risk EG0013 events3 affected46 at risk EG0022 events2 affected11 at risk EG003
Urine Odor Abnormal	Renal and urinary disorders	MedDRA version 14	Systematic Assessment		EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Urine Abnormality	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected46 at risk EG0013 events3 affected46 at risk EG0020 events0 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0013 events3 affected46 at risk EG0020 events0 affected11 at risk EG003
Fungal Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Bacterial Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Papilloma Viral Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	Vulvovaginal Candidiasis	EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0013 events2 affected46 at risk EG0021 events1 affected11 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Hypoesthesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Edema Peripheral	General disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk EG0021 events1 affected11 at risk EG003
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Pain	General disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Tenderness	General disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003
Blood Triglycerides Increased	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment		EG0000 events0 affected46 at risk EG0010 events0 affected46 at risk EG0021 events1 affected11 at risk EG003

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

ID	Title	Description
BG000	LiRIS® 400 Mg-Randomized Study	LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
BG001	LiRIS® Placebo-Randomized Study	LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
BG002	Sham Cystoscopic Procedure-Randomized Study	Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.
BG003	Total	Total of all reporting groups

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest Pain	General disorders	MedDRA version 14	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected46 at risk EG0020 events0 affected11 at risk EG0030 events0 affected56 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA version 14	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk EG0020 events0 affected11 at risk EG003
Cystitis Interstitial	Renal and urinary disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk EG0020 events0 affected11 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected46 at risk EG0020 events0 affected11 at risk EG003