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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01475253
Date of registration: 03/11/2011
Prospective Registration: No
Primary sponsor: Allergan
Public title: Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis
Scientific title: A Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating Safety, Tolerability and Efficacy of LiRIS® in Women With Interstitial Cystitis Followed by an Open Label Extension
Date of first enrolment: November 2011
Target sample size: 104
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01475253
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Canada United States
Contacts
Name:     Curtis Nickel, MD
Address: 
Telephone:
Email:
Affiliation:  Queen's University/Kingston General Hospital/Ontario Canada
Key inclusion & exclusion criteria

Inclusion Criteria:

- Women age 18 and over

- Diagnosed with Interstitial Cystitis as defined by protocol

- Able and willing to complete questionnaires and diary

- Able to comply with visit schedule including Day 14 Removal visit

- Completion of blinded study prior to enrolling in unblinded part of study

Exclusion Criteria:

- Pregnant or lactating women

- Bladder or urethra anatomical feature that would prevent the safe indwelling or
insertion of the investigational product

- History or presence of any condition that would make it difficult to evaluate symptoms

- Did not complete blinded study (unblinded part of study only)



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Interstitial Cystitis
Intervention(s)
Drug: Lidocaine Releasing Intravesical System - LiRIS®
Procedure: Sham Cystoscopy Procedure
Other: LiRIS Placebo
Primary Outcome(s)
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14 [Time Frame: Baseline, Day 14]
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42 [Time Frame: Baseline, Day 42]
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7 [Time Frame: Baseline, Day 7]
Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28 [Time Frame: Baseline, Day 28]
Secondary Outcome(s)
Change From Baseline in Urinary Urgency as Assessed by VAS [Time Frame: Baseline, Days 7, 14, 28 and 42]
Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score [Time Frame: Baseline, Days 7, 14, 28 and 42]
Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score [Time Frame: Baseline, Days 7, 14, 28 and 42]
Change From Baseline in Voiding Frequency [Time Frame: Baseline, Days 7, 14, 28 and 42]
Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings [Time Frame: Baseline, Day 14]
Percentage of Responders Using the Global Response Assessment (GRA) [Time Frame: Baseline, Days 7, 14, 28 and 42]
Secondary ID(s)
TAR-100-201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
TARIS Biomedical, Inc.
Ethics review
Results
Results available: Yes
Date Posted: 21/09/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01475253
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