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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
LiRIS 400 mg LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.

Participant Flow for 2 periods

Period 1:   Randomized Study
    LiRIS 400 mg   LiRIS Placebo
STARTED   16   14 
COMPLETED   14   13 
NOT COMPLETED   2   1 
Withdrawal by Subject                1                1 
Other Miscellaneous Reasons                1                0 

Period 2:   Open Label Extension
    LiRIS 400 mg   LiRIS Placebo
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.



  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 LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
LiRIS Placebo LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
Total Total of all reporting groups

Baseline Measures
   LiRIS 400 mg   LiRIS Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   14   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.7  (14.13)   42.1  (10.54)   41.9  (12.37) 
Gender 
[Units: Participants]
     
Female   16   14   30 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)   [ Time Frame: Baseline, Day 12 ]

2.  Secondary:   Change From Baseline in Total Daily Voids   [ Time Frame: Baseline, Day 27 ]

3.  Secondary:   Change From Baseline in Night-Time Daily Voids   [ Time Frame: Baseline, Day 27 ]

4.  Secondary:   Change From Baseline in Average Void Volume Per Micturition   [ Time Frame: Baseline, Day 27 ]

5.  Secondary:   Change From Baseline in Post-Void Bladder Pain   [ Time Frame: Baseline, Day 27 ]

6.  Secondary:   Change From Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score   [ Time Frame: Baseline, Day 27 ]

7.  Secondary:   Change From Baseline in O’Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score   [ Time Frame: Baseline, Day 27 ]

8.  Secondary:   Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)   [ Time Frame: Baseline, Day 27 ]

9.  Secondary:   Change From Baseline in Brief Pain Inventory (BPI)   [ Time Frame: Baseline, Day 27 ]


  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
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.


  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: 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