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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:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT01990898
Date of registration:	18/11/2013
Prospective Registration:	No
Primary sponsor:	The Cleveland Clinic
Public title:	Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action CIC
Scientific title:	Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action
Date of first enrolment:	November 2013
Target sample size:	26
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01990898
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 2

Countries of recruitment
United States

Contacts

Name:	Daniel Shoskes, M.D.
Address:
Telephone:
Email:
Affiliation:	The Cleveland Clinic

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Intervention(s)

Drug: Cyclosporine

Primary Outcome(s)

Symptom Improvement of Interstitial Cystitis [Time Frame: 3 Months]

Secondary Outcome(s)

Secondary ID(s)

13-1271

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	19/04/2017
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01990898

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