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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 February 2015 |
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Main ID: |
NCT01150565 |
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Date of registration:
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23/06/2010 |
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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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Safety Study of LiRIS in Interstitial Cystitis (IC) Patients
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Scientific title:
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Phase 1B Pilot Safety Study of LiRIS-TM, A Novel Bladder Drug Delivery Platform in Patients With Interstitial Cystitis |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01150565 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Curtis Nickel, 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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Queen's University/Kingston General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female patients = 18 years of age
- If of child-bearing potential, agrees to use effective contraception defined by
protocol
- Capable of understanding and completing symptom diaries and questionnaires as
required in the study
- Diagnosed with IC, as defined by protocol criteria
Exclusion Criteria:
- Bladder or urethra anatomical feature that, in the opinion of the investigator, might
prevent the safe placement, indwelling use, or removal of LiRIS
- History or presence of any medical condition that would interfere with ability to
assess symptoms
- Pregnant or lactating patients
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: LiRIS low dose and LiRIS high dose
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Primary Outcome(s)
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Cystoscopic examination
[Time Frame: Days 1 and 14]
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Secondary Outcome(s)
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Bladder pain
[Time Frame: During and following treatment; study days 1 to 90]
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Secondary ID(s)
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TAR-100-103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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