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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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.
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.
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.
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 label extension.

Participant Flow for 2 periods

Period 1:   Randomized, Blinded Study
    LiRIS® 400 mg - Randomized Study   LiRIS® Placebo-Randomized Study   Sham Cystoscopic Procedure-Randomized Study   LiRIS® 400 mg - Open Label Extension
STARTED   47   46   11   0 
COMPLETED   45   45   11   0 
NOT COMPLETED   2   1   0   0 
Withdrawal by Subject                1                1                0                0 
Lost to Follow-up                1                0                0                0 

Period 2:   Open Label Extension
    LiRIS® 400 mg - Randomized Study   LiRIS® Placebo-Randomized Study   Sham Cystoscopic Procedure-Randomized Study   LiRIS® 400 mg - Open Label Extension
STARTED   0   0   0   56 
COMPLETED   0   0   0   56 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
   LiRIS® 400 Mg-Randomized Study   LiRIS® Placebo-Randomized Study   Sham Cystoscopic Procedure-Randomized Study   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   46   11   104 
Age 
[Units: Participants]
       
<=18 years   1   0   0   1 
Between 18 and 65 years   42   39   11   92 
>=65 years   4   7   0   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.4  (14.76)   45.9  (15.85)   38.1  (12.90)   44.4  (15.12) 
Gender 
[Units: Participants]
       
Female   47   46   11   104 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   44   44   11   99 
Canada   3   2   0   5 


  Outcome Measures

1.  Primary:   Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7   [ Time Frame: Baseline, Day 7 ]

2.  Primary:   Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14   [ Time Frame: Baseline, Day 14 ]

3.  Primary:   Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28   [ Time Frame: Baseline, Day 28 ]

4.  Primary:   Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42   [ Time Frame: Baseline, Day 42 ]

5.  Secondary:   Percentage of Responders Using the Global Response Assessment (GRA)   [ Time Frame: Baseline, Days 7, 14, 28 and 42 ]

6.  Secondary:   Change From Baseline in Urinary Urgency as Assessed by VAS   [ Time Frame: Baseline, Days 7, 14, 28 and 42 ]

7.  Secondary:   Change From Baseline in Voiding Frequency   [ Time Frame: Baseline, Days 7, 14, 28 and 42 ]

8.  Secondary:   Change Form Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score   [ Time Frame: Baseline, Days 7, 14, 28 and 42 ]

9.  Secondary:   Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score   [ Time Frame: Baseline, Days 7, 14, 28 and 42 ]

10.  Secondary:   Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings   [ Time Frame: Baseline, Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group. Only safety analyses were completed.


  More Information

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.
The agreement is:
unchecked The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 more than 60 days but less than or equal to 180 days. 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
e-mail: clinicaltrials@allergan.com



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