Ignite Creation Date:
2024-05-06 @ 2:14 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01990898
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2013-11-18
Brief Title:
Cyclosporine in Interstitial Cystitis Efficacy Safety and Mechanism of Action
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Cyclosporine in Interstitial Cystitis Efficacy Safety and Mechanism of Action
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIC
Brief 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 unsuccessfullyeg 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 pain signals
This study is only being done at the Cleveland Clinic and will involve about 30 patients with Interstitial Cystitis
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 pain signals
This study is only being done at the Cleveland Clinic and will involve about 30 patients with Interstitial Cystitis
Detailed Description:
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 pain signals
This study is only being done at the Cleveland Clinic and will involve about 30 patients with Interstitial Cystitis
This study is only being done at the Cleveland Clinic and will involve about 30 patients with Interstitial Cystitis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None