Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT01475253 |
Date of registration:
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03/11/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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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Scientific title:
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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:
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November 2011 |
Target sample size:
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104 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT01475253 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Curtis Nickel, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Queen's University/Kingston General Hospital/Ontario Canada |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: Lidocaine Releasing Intravesical System - LiRIS®
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Procedure: Sham Cystoscopy Procedure
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Other: LiRIS Placebo
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Primary Outcome(s)
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Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42
[Time Frame: Baseline, Day 42]
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Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7
[Time Frame: Baseline, Day 7]
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Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28
[Time Frame: Baseline, Day 28]
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Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14
[Time Frame: Baseline, Day 14]
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Secondary Outcome(s)
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Change From Baseline in Urinary Urgency as Assessed by VAS
[Time Frame: Baseline, Days 7, 14, 28 and 42]
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Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score
[Time Frame: Baseline, Days 7, 14, 28 and 42]
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Change From Baseline in Voiding Frequency
[Time Frame: Baseline, Days 7, 14, 28 and 42]
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Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings
[Time Frame: Baseline, Day 14]
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Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
[Time Frame: Baseline, Days 7, 14, 28 and 42]
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Percentage of Responders Using the Global Response Assessment (GRA)
[Time Frame: Baseline, Days 7, 14, 28 and 42]
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Secondary ID(s)
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TAR-100-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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