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Trial record 67 of 158 for:    interstitial cystitis

A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome

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ClinicalTrials.gov Identifier: NCT02411110
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : January 4, 2018
Last Update Posted : January 4, 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
Painful Bladder Syndrome
Interventions Combination Product: LiRIS®
Combination Product: LiRIS Placebo
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2)
Hide Arm/Group Description Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
Period Title: Treatment Period 1
Started 65 66
Completed 56 59
Not Completed 9 7
Reason Not Completed
Adverse Event             4             2
Lost to Follow-up             1             0
Personal Reasons             2             5
Other Miscellaneous Reasons             2             0
Period Title: Treatment Period 2
Started 50 [1] 48 [1]
Completed 49 44
Not Completed 1 4
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             0             2
Personal Reasons             0             2
[1]
Period 2 was optional.
Arm/Group Title LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) Total
Hide Arm/Group Description Treatment Period 1: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. Total of all reporting groups
Overall Number of Baseline Participants 65 66 131
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 66 participants 131 participants
48.58  (14.50) 44.20  (12.65) 46.37  (13.73)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
< 40 Years 25 24 49
≥ 40 Years 40 42 82
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 66 participants 131 participants
Female
65
 100.0%
66
 100.0%
131
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up
Hide Description The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis.
Time Frame Baseline (Days -7 to 0) to Treatment 1 Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Analysis Population included all participants who were randomized and received Treatment 1.
Arm/Group Title LiRIS® (Treatment Period 1) LiRIS Placebo (Treatment Period 1)
Hide Arm/Group Description:
Treatment Period 1: LiRIS® (continuous release of lidocaine ) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1.
Overall Number of Participants Analyzed 65 66
Least Squares Mean (90% Confidence Interval)
Unit of Measure: score on a scale
-1.2
(-1.77 to -0.58)
-1.5
(-2.14 to -0.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LiRIS Placebo (Treatment Period 1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method ANCOVA
Comments Baseline value as a covariate; treatment group and stratification (age: < 40 or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.34
Estimation Comments LiRIS® - Placebo
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LiRIS Placebo (Treatment Period 1) LiRIS® (Treatment Period 1) LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Hide Arm/Group Description Treatment Period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 1: LiRIS® (continuous release of lidocaine ) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Participants who received Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. Participants who received LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1; followed by, LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2.
All-Cause Mortality
LiRIS Placebo (Treatment Period 1) LiRIS® (Treatment Period 1) LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LiRIS Placebo (Treatment Period 1) LiRIS® (Treatment Period 1) LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/66 (1.52%)   2/65 (3.08%)   1/48 (2.08%)   0/50 (0.00%) 
Infections and infestations         
Kidney infection  1  0/66 (0.00%)  1/65 (1.54%)  0/48 (0.00%)  0/50 (0.00%) 
Pneumonia  1  1/66 (1.52%)  0/65 (0.00%)  0/48 (0.00%)  0/50 (0.00%) 
Urinary tract infection  1  0/66 (0.00%)  0/65 (0.00%)  1/48 (2.08%)  0/50 (0.00%) 
Injury, poisoning and procedural complications         
Procedural pain  1  0/66 (0.00%)  1/65 (1.54%)  0/48 (0.00%)  0/50 (0.00%) 
Urinary tract stoma complication  1  0/66 (0.00%)  0/65 (0.00%)  1/48 (2.08%)  0/50 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis  1  0/66 (0.00%)  1/65 (1.54%)  0/48 (0.00%)  0/50 (0.00%) 
Reproductive system and breast disorders         
Pelvic congestion  1  0/66 (0.00%)  1/65 (1.54%)  0/48 (0.00%)  0/50 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (20.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LiRIS Placebo (Treatment Period 1) LiRIS® (Treatment Period 1) LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/66 (33.33%)   22/65 (33.85%)   4/48 (8.33%)   7/50 (14.00%) 
Gastrointestinal disorders         
Nausea  1  1/66 (1.52%)  4/65 (6.15%)  2/48 (4.17%)  2/50 (4.00%) 
Infections and infestations         
Urinary tract infection  1  16/66 (24.24%)  10/65 (15.38%)  4/48 (8.33%)  4/50 (8.00%) 
Vulvovaginal mycotic infection  1  4/66 (6.06%)  3/65 (4.62%)  0/48 (0.00%)  2/50 (4.00%) 
Viral upper respiratory tract infection  1  1/66 (1.52%)  1/65 (1.54%)  0/48 (0.00%)  3/50 (6.00%) 
Injury, poisoning and procedural complications         
Procedural pain  1  2/66 (3.03%)  6/65 (9.23%)  2/48 (4.17%)  0/50 (0.00%) 
Renal and urinary disorders         
Dysuria  1  11/66 (16.67%)  13/65 (20.00%)  0/48 (0.00%)  2/50 (4.00%) 
Urethral pain  1  4/66 (6.06%)  6/65 (9.23%)  3/48 (6.25%)  2/50 (4.00%) 
Bladder pain  1  5/66 (7.58%)  4/65 (6.15%)  1/48 (2.08%)  1/50 (2.00%) 
Haematuria  1  6/66 (9.09%)  2/65 (3.08%)  1/48 (2.08%)  1/50 (2.00%) 
Bladder discomfort  1  1/66 (1.52%)  5/65 (7.69%)  1/48 (2.08%)  1/50 (2.00%) 
Micturition urgency  1  1/66 (1.52%)  1/65 (1.54%)  0/48 (0.00%)  3/50 (6.00%) 
Pollakiuria  1  0/66 (0.00%)  1/65 (1.54%)  0/48 (0.00%)  3/50 (6.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (20.0)
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, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02411110     History of Changes
Other Study ID Numbers: 201025-002
First Submitted: April 3, 2015
First Posted: April 8, 2015
Results First Submitted: December 6, 2017
Results First Posted: January 4, 2018
Last Update Posted: January 4, 2018