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Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01824303
Recruitment Status : Terminated (This study was terminated early due to company decision.)
First Posted : April 4, 2013
Results First Posted : November 26, 2015
Last Update Posted : January 26, 2016
Sponsor:
Collaborator:
TARIS Biomedical, Inc.
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Interventions Drug: LiRIS 400 mg
Other: LiRIS Placebo
Enrollment 31
Recruitment Details  
Pre-assignment Details 31 participants signed the informed consent form and were enrolled in the study, 30 participants had the investigational product inserted and are included the Intent-to-treat Population.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Period Title: Randomized Study
Started 16 14
Completed 14 13
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             1
Other Miscellaneous Reasons             1             0
Period Title: Open Label Extension
Started 12 [1] 11 [1]
Completed 12 11
Not Completed 0 0
[1]
2 participants completed the Randomized Study but did not enter the Open Label Extension.
Arm/Group Title LiRIS 400 mg LiRIS Placebo Total
Hide Arm/Group Description LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days. LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
41.7  (14.13) 42.1  (10.54) 41.9  (12.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
16
 100.0%
14
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)
Hide Description Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: unit on a scale
Baseline 7.04  (0.750) 7.67  (1.067)
Change from Baseline at Day 12 -1.44  (1.584) -2.50  (2.723)
2.Secondary Outcome
Title Change From Baseline in Total Daily Voids
Hide Description Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: voids
Baseline 13.4  (6.52) 14.9  (7.81)
Change from Baseline at Day 27 (n=15,14) -2.9  (4.64) -3.3  (4.93)
3.Secondary Outcome
Title Change From Baseline in Night-Time Daily Voids
Hide Description Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: voids
Baseline 2.4  (2.56) 2.1  (2.37)
Change from Baseline at Day 27 (n=15,14) -0.5  (2.09) -0.9  (2.00)
4.Secondary Outcome
Title Change From Baseline in Average Void Volume Per Micturition
Hide Description Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: mL
Baseline 141.1  (80.26) 120.3  (73.06)
Change from Baseline at Day 27 (n=14,12) -2.2  (73.31) -0.5  (43.86)
5.Secondary Outcome
Title Change From Baseline in Post-Void Bladder Pain
Hide Description Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=13,11) 4.86  (1.857) 6.17  (1.925)
Change from Baseline at Day 27 (n=12,10) -1.05  (1.805) -1.69  (1.997)
6.Secondary Outcome
Title Change From Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
Hide Description The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 14.1  (3.70) 14.2  (2.73)
Change from Baseline at Day 27 (n=14,12) -1.4  (3.79) -2.8  (3.04)
7.Secondary Outcome
Title Change From Baseline in O’Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score
Hide Description The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 12.4  (2.87) 13.9  (1.66)
Change from Baseline at Day 27 (n=14,12) -1.3  (3.52) -3.2  (3.46)
8.Secondary Outcome
Title Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
Hide Description The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=16,13) 28.8  (4.16) 31.2  (3.00)
Change from Baseline at Day 27 (n=14,12) -4.0  (5.75) -7.1  (7.81)
9.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI)
Hide Description The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement.
Time Frame Baseline, Day 27
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population, all randomized participants, with data available for analyses.
Arm/Group Title LiRIS 400 mg LiRIS Placebo
Hide Arm/Group Description:
LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Overall Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=16,13) 6.5  (1.10) 7.2  (1.99)
Change from Baseline at Day 27 (n=14,12) -1.2  (2.52) -2.3  (2.21)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LiRIS 400 mg_Randomized Study LiRIS Placebo_Randomized Study LiRIS 400 mg_Open Label Extension LiRIS Placebo/LiRIS 400 mg _Open Label Extension
Hide Arm/Group Description LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study. LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study. LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension. LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
All-Cause Mortality
LiRIS 400 mg_Randomized Study LiRIS Placebo_Randomized Study LiRIS 400 mg_Open Label Extension LiRIS Placebo/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 LiRIS 400 mg_Open Label Extension LiRIS Placebo/LiRIS 400 mg _Open Label Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%)   0/12 (0.00%)   0/11 (0.00%) 
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 LiRIS 400 mg_Open Label Extension LiRIS Placebo/LiRIS 400 mg _Open Label Extension
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/16 (68.75%)   12/14 (85.71%)   6/12 (50.00%)   6/11 (54.55%) 
Eye disorders         
Conjunctivitis  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Gastrointestinal disorders         
Vomiting  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Abdominal pain lower  1  0/16 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/11 (9.09%) 
Immune system disorders         
Allergy to arthropod bite  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Allergy to arthropod sting  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Infections and infestations         
Urinary tract infection  1  1/16 (6.25%)  2/14 (14.29%)  2/12 (16.67%)  1/11 (9.09%) 
Nasopharyngitis  1  1/16 (6.25%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Cystitis  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Genital herpes  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Sinusitis  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  2/11 (18.18%) 
Tooth abscess  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Fungal infection  1  0/16 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/11 (0.00%) 
Lower respiratory tract infection  1  0/16 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/11 (0.00%) 
Tonsillitis  1  0/16 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/11 (9.09%) 
Vulvovaginal mycotic infection  1  0/16 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/11 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Investigations         
Blood creatine phosphokinase increased  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Residual urine volume increased  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Vitamin D decreased  1  0/16 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Nervous system disorders         
Dizziness  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Headache  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Migraine  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Burning sensation  1  0/16 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/11 (9.09%) 
Psychiatric disorders         
Anxiety  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Depression  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  1/11 (9.09%) 
Renal and urinary disorders         
Dysuria  1  4/16 (25.00%)  4/14 (28.57%)  0/12 (0.00%)  2/11 (18.18%) 
Bladder pain  1  2/16 (12.50%)  3/14 (21.43%)  0/12 (0.00%)  1/11 (9.09%) 
Bladder discomfort  1  2/16 (12.50%)  2/14 (14.29%)  1/12 (8.33%)  0/11 (0.00%) 
Pollakiuria  1  1/16 (6.25%)  2/14 (14.29%)  0/12 (0.00%)  1/11 (9.09%) 
Haematuria  1  0/16 (0.00%)  2/14 (14.29%)  0/12 (0.00%)  0/11 (0.00%) 
Urethral pain  1  2/16 (12.50%)  0/14 (0.00%)  1/12 (8.33%)  1/11 (9.09%) 
Bladder spasm  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Cystitis interstitial  1  1/16 (6.25%)  0/14 (0.00%)  1/12 (8.33%)  2/11 (18.18%) 
Micturition urgency  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Nocturia  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Urinary incontinence  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  1/11 (9.09%) 
Urethritis noninfective  1  0/16 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  1/11 (9.09%) 
Reproductive system and breast disorders         
Dysfunctional uterine bleeding  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Pelvic discomfort  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Vaginal haemorrhage  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  1/16 (6.25%)  0/14 (0.00%)  0/12 (0.00%)  0/11 (0.00%) 
Dry skin  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Rash  1  0/16 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/11 (0.00%) 
Vascular disorders         
Hypertension  1  1/16 (6.25%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Pallor  1  0/16 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Due to technical issues with the patient electronic diary used for the collection of the outcome measures data, as well as the small evaluable sample size and large variability, the efficacy data should be interpreted with caution.
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: NCT01824303     History of Changes
Other Study ID Numbers: TAR-100-202
First Submitted: March 31, 2013
First Posted: April 4, 2013
Results First Submitted: October 23, 2015
Results First Posted: November 26, 2015
Last Update Posted: January 26, 2016