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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02395042 |
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Date of registration:
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17/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
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Scientific title:
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A Multicenter, Randomized, Double-blind, Placebo-controlled Study, Evaluating Safety and Efficacy of LiRIS® 400 mg in Females With Interstitial Cystitis With Hunner's Lesions |
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Date of first enrolment:
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April 15, 2015 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02395042 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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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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Till Geib |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
Exclusion Criteria:
- Previous treatment with LiRIS®
- Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
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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Ulcer
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Cystitis, Interstitial
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Intervention(s)
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Drug: LiRIS Placebo
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Drug: LiRIS®
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Primary Outcome(s)
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Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)
[Time Frame: Baseline (Day -7 to Day 0) to Week 4]
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Secondary Outcome(s)
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Change From Baseline in the Number of Hunner's Lesions
[Time Frame: Baseline (Day 0) to Week 4]
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Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions
[Time Frame: Baseline (Day 1) to Week 4]
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Secondary ID(s)
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201025-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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