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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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19 October 2017 |
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Main ID: |
NCT01879683 |
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Date of registration:
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10/06/2013 |
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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, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
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Scientific title:
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A Phase 1b, Multicenter, Open Label Study Evaluating Safety, Tolerability and Preliminary Efficacy of LiRIS® 400 mg in Women With Ulcerative Interstitial Cystitis |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01879683 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Kenneth Peters, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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William Beaumont Hospitals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women age 18 and older
- Interstitial Cystitis with history of Hunner's lesions in the bladder
- Moderate to severe bladder discomfort
- Confirmation of Hunner's lesions in Bladder
- Able to report symptom (pain and voiding frequency) in a diary throughout the study
Exclusion Criteria:
- Pregnant women
- History or presence of bladder cancer
- History or presence of any condition that would make it difficult to evaluate bladder
symptoms
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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Chronic Interstitial Cystitis
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Intervention(s)
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Drug: LiRIS® 400 mg
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Primary Outcome(s)
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Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14
[Time Frame: Baseline, Day 14]
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Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28
[Time Frame: Baseline, Day 28]
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Secondary Outcome(s)
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Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain
[Time Frame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)]
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Change From Baseline in Patient Reported IC Symptom: Daily Total Voids
[Time Frame: Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)]
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Secondary ID(s)
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TAR-100-105
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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