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NCT01990898 · ClinicalTrials.gov registry record · Phase 2
Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT01990898 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 26 participants.
The verdict
NCT01990898, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a study for patients that have a condition called Interstitial Cystitis, also known as Painful Bladder Syndrome. Patients would have tried at least two different therapies, unsuccessfully,(eg. medications, pelvic floor physical therapy) The purpose of this research project is to study the immunosuppressive drug Cyclosporine in patients with Interstitial Cystitis to assess how well it works, what the side effects are and what is its mechanism of action. Cyclosporine is a drug that is FDA-approved to prevent organ rejection after kidney, liver, and heart transplant but is not approved by the FDA for Interstitial Cystitis. Several research studies have been published showing that Cyclosporine can improve the symptoms of Interstitial Cystitis, that it works better than a placebo ("sugar pill" or inert treatment) and that it works more effectively than Pentosan Polysulfate (Elmiron), which is an FDA approved therapy. The dose of Cyclosporine used in these studies on Interstitial Cystitis are much lower that the doses used to prevent rejection in transplant patients. Based on these studies, the American Urological Association has recently published treatment guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure of other more conservative therapies and medications. Nevertheless, much is not known about using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the ideal dose, how best to monitor for side effects and in particular whether kidney damage can occur at the low doses used in these studies. In this study, to examine the mechanism of action, blood and urine samples will be collected before, during and after therapy to look at "biomarkers", chemical substances that can be associated with inflammation and tissue injury. We will also test effects of therapy on skin sensation and pain perception because the molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct
Interventions
- DRUG Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01990898
The ClinicalTrials.gov registry entry for NCT01990898 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cyclosporine is the first listed.
NCT01990898 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01990898 about?
NCT01990898 is a clinical study titled "Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action". This is a study for patients that have a condition called Interstitial Cystitis, also known as Painful Bladder Syndrome. Patients would have tried at least two different therapies, unsuccessfully,(eg. medications, pelvic floor physical therapy) The purpose of this research project is to study the i...
What is the current status of trial NCT01990898?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2013-11. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01990898?
The interventions under investigation include: Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT01990898?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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