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Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT01475253
Recruitment Status : Terminated (This study was not enrolled completely and was terminated.)
First Posted : November 21, 2011
Results First Posted : September 21, 2015
Last Update Posted : September 21, 2015
Sponsor:
Collaborator:
TARIS Biomedical, Inc.
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Interventions Drug: Lidocaine Releasing Intravesical System - LiRIS®
Other: LiRIS Placebo
Procedure: Sham Cystoscopy Procedure
Enrollment 104

Recruitment Details Study subjects were recruited by clinical centers that saw subjects meeting eligibility criteria and were capable of undergoing cystoscopy per protocol specifications. The first subject was enrolled 28 November 2011.
Pre-assignment Details In addition to meeting all protocol defined inclusion/exclusion criteria, participants were required to be females with a confirmed diagnosis of moderate to severe Interstitial Cystitis (IC) according to the 1987 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) symptom severity criteria (modified to exclude cystometry).
Arm/Group Title LiRIS® 400 mg - Randomized Study LiRIS® Placebo-Randomized Study Sham Cystoscopic Procedure-Randomized Study LiRIS® 400 mg - Open Label Extension
Hide Arm/Group Description 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. 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. Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo. 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 label extension.
Period Title: Randomized, Blinded Study
Started 47 46 11 0
Completed 45 45 11 0
Not Completed 2 1 0 0
Reason Not Completed
Withdrawal by Subject             1             1             0             0
Lost to Follow-up             1             0             0             0
Period Title: Open Label Extension
Started 0 0 0 56
Completed 0 0 0 56
Not Completed 0 0 0 0
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study Sham Cystoscopic Procedure-Randomized Study Total
Hide Arm/Group Description 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. 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. Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo. Total of all reporting groups
Overall Number of Baseline Participants 47 46 11 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 46 participants 11 participants 104 participants
<=18 years
1
   2.1%
0
   0.0%
0
   0.0%
1
   1.0%
Between 18 and 65 years
42
  89.4%
39
  84.8%
11
 100.0%
92
  88.5%
>=65 years
4
   8.5%
7
  15.2%
0
   0.0%
11
  10.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 46 participants 11 participants 104 participants
44.4  (14.76) 45.9  (15.85) 38.1  (12.90) 44.4  (15.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 46 participants 11 participants 104 participants
Female
47
 100.0%
46
 100.0%
11
 100.0%
104
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 46 participants 11 participants 104 participants
United States 44 44 11 99
Canada 3 2 0 5
1.Primary Outcome
Title Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
Hide Description 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.
Time Frame Baseline, Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: centimeters
-1.25  (2.45) -0.84  (1.92)
2.Primary Outcome
Title Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
Hide Description 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.
Time Frame Baseline, Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: centimeters
-0.81  (2.50) -0.45  (2.45)
3.Primary Outcome
Title Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
Hide Description 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.
Time Frame Baseline, Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: centimeters
-0.92  (2.36) -1.36  (2.28)
4.Primary Outcome
Title Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
Hide Description 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.
Time Frame Baseline, Day 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 40
Mean (Standard Deviation)
Unit of Measure: centimeters
-0.89  (2.58) -1.40  (2.51)
5.Secondary Outcome
Title Percentage of Responders Using the Global Response Assessment (GRA)
Hide Description 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.
Time Frame Baseline, Days 7, 14, 28 and 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 40
Measure Type: Number
Unit of Measure: Percentage of Responders
Day 7 24 18
Day 14 17 20
Day 28 7 25
Day 42 12 21
6.Secondary Outcome
Title Change From Baseline in Urinary Urgency as Assessed by VAS
Hide Description 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.
Time Frame Baseline, Days 7, 14, 28 and 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: centimeters
Change from Baseline at Day 7 0.66  (2.66) -1.45  (2.69)
Change from Baseline at Day 14 -0.76  (3.14) -1.00  (2.74)
Change from Baseline at Day 28 -1.01  (2.93) -1.77  (2.70)
Change from Baseline at Day 42 -0.30  (2.01) -0.84  (2.74)
7.Secondary Outcome
Title Change From Baseline in Voiding Frequency
Hide Description 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.
Time Frame Baseline, Days 7, 14, 28 and 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: Voids
Change from Baseline at Day 7 -7.3  (12.6) -1.1  (20.3)
Change from Baseline at Day 14 -8.8  (13.2) -5.8  (13.1)
Change from Baseline at Day 28 -9.3  (15.9) -8.4  (12.8)
Change from Baseline at Day 42 -9.8  (15.3) -7.2  (13.2)
8.Secondary Outcome
Title Change Form Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Hide Description 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
Time Frame Baseline, Days 7, 14, 28 and 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline at Day 7 -2.39  (3.18) -2.00  (3.56)
Change from Baseline at Day 14 -2.02  (3.90) -1.97  (3.82)
Change from Baseline at Day 28 -2.93  (3.83) -2.87  (3.68)
Change from Baseline at Day 42 -2.83  (4.11) -2.32  (3.64)
9.Secondary Outcome
Title Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
Hide Description 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.
Time Frame Baseline, Days 7, 14, 28 and 42
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change from Baseline at Day 7 -2.24  (2.74) -1.54  (2.97)
Change from Baseline at Day 14 -2.33  (2.92) -1.62  (3.21)
Change from Baseline at Day 28 -2.98  (3.14) -2.23  (3.26)
Change from Baseline at Day 42 -2.48  (3.09) -1.58  (3.01)
10.Secondary Outcome
Title Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
Hide Description 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.
Time Frame Baseline, Day 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS® 400 Mg-Randomized Study LiRIS® Placebo-Randomized Study
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 46 46
Measure Type: Number
Unit of Measure: percentage of participants
Bladder Mucosal Erythema:Improvement 35 15
Bladder Mucosal Erythema:Worsening 13 11
Bladder Mucosal Erythema:No Change 50 70
Bladder Mucosal Erythema:Not Done 2 4
Hunner’s Lesions:Improvement 2 9
Hunner’s Lesions:Worsening 2 2
Hunner’s Lesions:No Change 96 89
Stricture:Improvement 0 0
Stricture:Worsening 0 0
Stricture:No Change 100 100
Time Frame Adverse Events (AEs) and Serious Adverse Events (SAEs) reporting was collected from the time of Day of insertion through the duration of study participation (Randomized and Open Label phases).[Up to 18 Weeks]
Adverse Event Reporting Description The Intent-to-treat population, all enrolled participants for whom the study insertion procedure was initiated, was used for all safety analyses and was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
 
Arm/Group Title LiRIS® 400 mg - Randomized Study LiRIS® Placebo - Randomized Study Sham Cystoscopic Procedure - Randomized Study LiRIS 400 mg - Open Label Extension
Hide Arm/Group Description 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. 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. Single-blinded "sham" arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo.

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.

All-Cause Mortality
LiRIS® 400 mg - Randomized Study LiRIS® Placebo - Randomized Study Sham Cystoscopic Procedure - Randomized Study LiRIS 400 mg - Open Label Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LiRIS® 400 mg - Randomized Study LiRIS® Placebo - Randomized Study Sham Cystoscopic Procedure - Randomized Study LiRIS 400 mg - Open Label Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/46 (2.17%)      2/46 (4.35%)      0/11 (0.00%)      0/56 (0.00%)    
General disorders         
Chest Pain  1  1/46 (2.17%)  1 0/46 (0.00%)  0 0/11 (0.00%)  0 0/56 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Rotator Cuff Syndrome  1  0/46 (0.00%)  0 1/46 (2.17%)  1 0/11 (0.00%)  0 0/56 (0.00%)  0
Renal and urinary disorders         
Cystitis Interstitial  2  0/46 (0.00%)  0 1/46 (2.17%)  1 0/11 (0.00%)  0 0/56 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Hypoxia  2  0/46 (0.00%)  0 1/46 (2.17%)  1 0/11 (0.00%)  0 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14
2
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LiRIS® 400 mg - Randomized Study LiRIS® Placebo - Randomized Study Sham Cystoscopic Procedure - Randomized Study LiRIS 400 mg - Open Label Extension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/46 (50.00%)      23/46 (50.00%)      7/11 (63.64%)      29/56 (51.79%)    
Gastrointestinal disorders         
Diarrhea  2  3/46 (6.52%)  3 1/46 (2.17%)  1 0/11 (0.00%)  0 2/56 (3.57%)  2
Abdominal Pain (Lower)  2  2/46 (4.35%)  2 3/46 (6.52%)  3 0/11 (0.00%)  0 1/56 (1.79%)  1
Abdominal Pain  2  1/46 (2.17%)  1 3/46 (6.52%)  3 2/11 (18.18%)  2 0/56 (0.00%)  0
Nausea  2  1/46 (2.17%)  1 3/46 (6.52%)  3 0/11 (0.00%)  0 2/56 (3.57%)  2
Vomiting  2  0/46 (0.00%)  0 3/46 (6.52%)  3 0/11 (0.00%)  0 3/56 (5.36%)  3
General disorders         
Headache  2  3/46 (6.52%)  3 3/46 (6.52%)  5 0/11 (0.00%)  0 2/56 (3.57%)  3
Edema Peripheral  2  0/46 (0.00%)  0 1/46 (2.17%)  1 1/11 (9.09%)  1 2/56 (3.57%)  3
Fatigue  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 1/56 (1.79%)  1
Pain  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 1/56 (1.79%)  1
Tenderness  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Infections and infestations         
Fungal Infection  2  1/46 (2.17%)  1 0/46 (0.00%)  0 1/11 (9.09%)  1 3/56 (5.36%)  3
Bacterial Infection  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Papilloma Viral Infection  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Vulvovaginal Mycotic Infection  2 [1]  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Metabolism and nutrition disorders         
Blood Triglycerides Increased  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Pain in Extremity  2  0/46 (0.00%)  0 2/46 (4.35%)  3 1/11 (9.09%)  1 1/56 (1.79%)  1
Arthralgia  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Nervous system disorders         
Hypoesthesia  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Renal and urinary disorders         
Dysuria  1  11/46 (23.91%)  13 7/46 (15.22%)  8 0/11 (0.00%)  0 9/56 (16.07%)  12
Bladder Pain  2  8/46 (17.39%)  9 11/46 (23.91%)  12 1/11 (9.09%)  1 9/56 (16.07%)  10
Bladder Discomfort  2  5/46 (10.87%)  5 2/46 (4.35%)  2 0/11 (0.00%)  0 1/56 (1.79%)  1
Hematuria  2  7/46 (15.22%)  7 2/46 (4.35%)  2 1/11 (9.09%)  1 6/56 (10.71%)  6
Urethral Pain  2  4/46 (8.70%)  5 3/46 (6.52%)  5 0/11 (0.00%)  0 4/56 (7.14%)  4
Urinary Tract Infection  2  4/46 (8.70%)  4 2/46 (4.35%)  2 1/11 (9.09%)  1 7/56 (12.50%)  8
Micturition Urgency  2  3/46 (6.52%)  4 4/46 (8.70%)  4 0/11 (0.00%)  0 1/56 (1.79%)  1
Bladder Irritation  2  3/46 (6.52%)  3 0/46 (0.00%)  0 0/11 (0.00%)  0 1/56 (1.79%)  2
Pollakiuria  2  2/46 (4.35%)  2 3/46 (6.52%)  4 0/11 (0.00%)  0 3/56 (5.36%)  3
Urine Odor Abnormal  1  1/46 (2.17%)  1 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Urine Abnormality  2  0/46 (0.00%)  0 0/46 (0.00%)  0 1/11 (9.09%)  1 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14
2
Term from vocabulary, MedDRA 14.0
[1]
Vulvovaginal Candidiasis
As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. Only safety analyses were completed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01475253     History of Changes
Other Study ID Numbers: TAR-100-201
First Submitted: November 3, 2011
First Posted: November 21, 2011
Results First Submitted: August 5, 2014
Results First Posted: September 21, 2015
Last Update Posted: September 21, 2015