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Trial record 85 of 158 for:    interstitial cystitis

A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

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ClinicalTrials.gov Identifier: NCT02395042
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Cystitis, Interstitial
Ulcer
Interventions Drug: LiRIS®
Drug: LiRIS Placebo
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Hide Arm/Group Description 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. 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. 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.
Period Title: Treatment 1 Period
Started 12 31 16
Completed 9 25 14
Not Completed 3 6 2
Reason Not Completed
Adverse Event             1             3             1
Lack of Efficacy             1             1             0
Lost to Follow-up             1             0             0
Other Miscellaneous Reasons             0             2             1
Period Title: Treatment 2 Period
Started 10 [1] 24 [1] 13 [1]
Completed 9 23 13
Not Completed 1 1 0
Reason Not Completed
Lack of Efficacy             1             1             0
[1]
Not all participants participated in Treatment 2 Period.
Arm/Group Title LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 12 31 16 59
Hide Baseline Analysis Population Description
Modified Intent-to-treat (mITT) Population included all randomized participants who had the investigational product inserted.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 31 participants 16 participants 59 participants
53.58  (12.09) 57.65  (12.76) 57.31  (14.25) 56.73  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 31 participants 16 participants 59 participants
Female
12
 100.0%
31
 100.0%
16
 100.0%
59
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 12 participants 31 participants 16 participants 59 participants
8
  66.7%
29
  93.5%
16
 100.0%
53
  89.8%
Black Number Analyzed 12 participants 31 participants 16 participants 59 participants
3
  25.0%
1
   3.2%
0
   0.0%
4
   6.8%
Asian Number Analyzed 12 participants 31 participants 16 participants 59 participants
0
   0.0%
1
   3.2%
0
   0.0%
1
   1.7%
Hispanic Number Analyzed 12 participants 31 participants 16 participants 59 participants
1
   8.3%
0
   0.0%
0
   0.0%
1
   1.7%
Daily Average Bladder Pain Numeric Rating Scale (NRS)   [1] [2] 
Mean (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 11 participants 28 participants 14 participants 53 participants
6.0
(4.3 to 8.0)
5.5
(3.2 to 9.3)
5.6
(4.1 to 7.8)
5.7
(3.2 to 9.3)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with available baseline data.
1.Primary Outcome
Title Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
Hide Description 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.
Time Frame Baseline (Day -7 to Day 0) to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.
Arm/Group Title LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 9 26 10
Least Squares Mean (90% Confidence Interval)
Unit of Measure: score on a scale
-1.6
(-2.68 to -0.45)
-2.7
(-3.36 to -2.06)
-2.5
(-3.53 to -1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.92
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Number of Hunner's Lesions
Hide Description 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.
Time Frame Baseline (Day 0) to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.
Arm/Group Title LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 18 12
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Hunner's lesions
0.8
(-0.04 to 1.7)
-0.6
(-1.21 to -0.05)
-0.2
(-0.87 to 0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2), LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.02
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
Hide Description 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.
Time Frame Baseline (Day 1) to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2)
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days
Adverse Event Reporting 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.
 
Arm/Group Title LiRIS Placebo, LiRIS Placebo (Tx 1) LiRIS®, LiRIS® (Tx 1) LiRIS Placebo, LiRIS® (Tx 1) LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2) LiRIS®, LiRIS® /LiRIS® (Tx 2) LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
All-Cause Mortality
LiRIS Placebo, LiRIS Placebo (Tx 1) LiRIS®, LiRIS® (Tx 1) LiRIS Placebo, LiRIS® (Tx 1) LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2) LiRIS®, LiRIS® /LiRIS® (Tx 2) LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/31 (0.00%)   0/16 (0.00%)   0/10 (0.00%)   0/24 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LiRIS Placebo, LiRIS Placebo (Tx 1) LiRIS®, LiRIS® (Tx 1) LiRIS Placebo, LiRIS® (Tx 1) LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2) LiRIS®, LiRIS® /LiRIS® (Tx 2) LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/12 (8.33%)   0/31 (0.00%)   0/16 (0.00%)   0/10 (0.00%)   0/24 (0.00%)   0/13 (0.00%) 
Infections and infestations             
Urosepsis  1  1/12 (8.33%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LiRIS Placebo, LiRIS Placebo (Tx 1) LiRIS®, LiRIS® (Tx 1) LiRIS Placebo, LiRIS® (Tx 1) LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2) LiRIS®, LiRIS® /LiRIS® (Tx 2) LiRIS Placebo, LiRIS /LiRIS® (Tx 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/12 (75.00%)   21/31 (67.74%)   10/16 (62.50%)   4/10 (40.00%)   2/24 (8.33%)   3/13 (23.08%) 
Gastrointestinal disorders             
Constipation  1  0/12 (0.00%)  1/31 (3.23%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Diarrhoea  1  1/12 (8.33%)  1/31 (3.23%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Nausea  1  0/12 (0.00%)  1/31 (3.23%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Vomiting  1  1/12 (8.33%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Abdominal pain upper  1  1/12 (8.33%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Dry mouth  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Dyspepsia  1  0/12 (0.00%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  1/13 (7.69%) 
General disorders             
Medical device pain  1  0/12 (0.00%)  2/31 (6.45%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Suprapubic pain  1  1/12 (8.33%)  2/31 (6.45%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Fatigue  1  0/12 (0.00%)  1/31 (3.23%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Medical device discomfort  1  0/12 (0.00%)  2/31 (6.45%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Thirst  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Infections and infestations             
Urinary tract infection  1  0/12 (0.00%)  5/31 (16.13%)  2/16 (12.50%)  0/10 (0.00%)  0/24 (0.00%)  1/13 (7.69%) 
Genital herpes  1  0/12 (0.00%)  1/31 (3.23%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Sinusitis  1  0/12 (0.00%)  2/31 (6.45%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Herpes virus infection  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Nasopharyngitis  1  1/12 (8.33%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Urosepsis  1  1/12 (8.33%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Genital infection fungal  1  0/12 (0.00%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  1/13 (7.69%) 
Tooth abscess  1  0/12 (0.00%)  0/31 (0.00%)  0/16 (0.00%)  1/10 (10.00%)  0/24 (0.00%)  0/13 (0.00%) 
Injury, poisoning and procedural complications             
Procedural pain  1  0/12 (0.00%)  1/31 (3.23%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Arthropod bite  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Investigations             
Liver function test increased  1  0/12 (0.00%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders             
Groin pain  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Nervous system disorders             
Dysgeusia  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Somnolence  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Headache  1  0/12 (0.00%)  0/31 (0.00%)  0/16 (0.00%)  1/10 (10.00%)  0/24 (0.00%)  0/13 (0.00%) 
Psychiatric disorders             
Anxiety  1  1/12 (8.33%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Depression  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Renal and urinary disorders             
Dysuria  1  5/12 (41.67%)  6/31 (19.35%)  3/16 (18.75%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Bladder pain  1  1/12 (8.33%)  3/31 (9.68%)  3/16 (18.75%)  1/10 (10.00%)  1/24 (4.17%)  0/13 (0.00%) 
Haematuria  1  0/12 (0.00%)  4/31 (12.90%)  2/16 (12.50%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Bladder discomfort  1  0/12 (0.00%)  4/31 (12.90%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Bladder spasm  1  0/12 (0.00%)  1/31 (3.23%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Leukocyturia  1  1/12 (8.33%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Urethral pain  1  0/12 (0.00%)  0/31 (0.00%)  2/16 (12.50%)  1/10 (10.00%)  1/24 (4.17%)  0/13 (0.00%) 
Micturition urgency  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Nephrolithiasis  1  1/12 (8.33%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Urge incontinence  1  0/12 (0.00%)  0/31 (0.00%)  1/16 (6.25%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
Urinary retention  1  1/12 (8.33%)  0/31 (0.00%)  0/16 (0.00%)  0/10 (0.00%)  0/24 (0.00%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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.
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.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02395042     History of Changes
Other Study ID Numbers: 201025-001
First Submitted: March 17, 2015
First Posted: March 20, 2015
Results First Submitted: June 29, 2018
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018