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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16 December 2017 |
Main ID: |
NCT01990898 |
Date of registration:
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18/11/2013 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action
CIC |
Scientific title:
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Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action |
Date of first enrolment:
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November 2013 |
Target sample size:
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26 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01990898 |
Study type:
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Interventional |
Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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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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Daniel Shoskes, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. age > 18
2. able to give consent
3. commitment to return for follow up appointments
4. agree to all parts of the study, including pain sensation testing
5. total Interstitial Cystitis Symptom Index (ICSI) score >9
Exclusion Criteria:
1. active cancer
2. history of pelvic radiation
3. history of previous urological malignancy
4. serum Cr > 1.5 mg/dl
5. diagnosis of diabetes mellitus types I or II
6. untreated hypertension or blood pressure on treatment > 140/90
7. proteinuria at enrollment
8. current or previous urinary diversion or bladder augmentation
9. chronic use of a medication class with significant impact on Cyclosporine A (CyA)
blood levels (eg. macrolide antibiotics, phenytoin, oral antifungals, calcium channel
blockers)
10. untreated urinary tract infection
11. pregnant or breast feeding
12. neurological impairment or spinal cord injury
13. known hypersensitivity to CyA
14. concurrent use of another immunosuppressive drug (eg. oral corticosteroids,
tacrolimus, mycophenolate mofetil)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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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: Cyclosporine
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Primary Outcome(s)
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Symptom Improvement of Interstitial Cystitis
[Time Frame: 3 Months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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