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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR ELMIRON

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Clinical Trials for Elmiron

Trial ID Title Status Sponsor Phase Summary
NCT00086684 Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis Terminated Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 4 The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.
NCT00236990 An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland Completed Alza Corporation, DE, USA Phase 2 The purpose of this study is to evaluate the safety and effectiveness of ELMIRON® in the treatment of chronic non-bacterial inflammation of the prostate gland.
NCT00236990 An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Phase 2 The purpose of this study is to evaluate the safety and effectiveness of ELMIRON® in the treatment of chronic non-bacterial inflammation of the prostate gland.
NCT00451867 A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . . Terminated National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 The purpose of this study is to investigate the safety and effectiveness of a medication called CellCept in treating refractory (has not responded to other treatments) interstitial cystitis. CellCept belongs to a class of medications called immuno-suppressants. Immuno-suppressants work in the body by reducing the immune system's ability to produce certain reactions that can cause inflammation. In some people, the inflammation produced by their immune system can damage healthy tissues and cause symptoms of pain and discomfort. CellCept is approved by the U.S. Food and Drug Administration (FDA) for use in patients who have had an organ transplant. When used in combination with other drugs, CellCept helps to prevent the rejection of the transplanted organ and is used widely in patients who have received kidney, liver and heart transplants. CellCept is also frequently used but not FDA approved for the treatment of severe rheumatoid arthritis which is a disease caused when the body's immune system acts against healthy tissues in the joints. Due to its special activity, CellCept may be useful in treating certain inflammatory diseases or conditions like interstitial cystitis.
NCT01990898 Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action Completed The Cleveland Clinic Phase 2 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 pain signals. This study is only being done at the Cleveland Clinic and will involve about 30 patients with Interstitial Cystitis.
NCT02930005 Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders Enrolling by invitation The University of Texas Health Science Center, Houston Phase 2 This study evaluates the feasibility of administering meclofenamic acid or pentosan polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic disorder. Half of participants will receive meclofenamic acid, while the other half will receive polysulfate sodium.
NCT03549650 Prevention and Management of Intravesical BCG-related Lower Urinary Tract Symptoms Not yet recruiting Cancer Research Network Phase 2 Common local side effects are generally seen during induction and during the first 6 months of BCG maintenance. BCG-related cystitis is frequent and unavoidable. Furthermore, repeated BCG instillation increases the incidence and severity of irritative bladder symptoms. Several methods attempted to reduce the intensity and frequency of BCG- related lower urinary tract symptoms (LUTS), such as, administration of anti-tuberculosis drug isoniazid or oral antibiotic ofloxacin or by reducing the BCG dose, but without any encouraging results. Local side effects requiring cessation of treatment are seen more frequently in the first year of therapy, preventing patients from receiving their BCG maintenance regimen. Pentosan Polysulphate (PPS), is an oral medication with unique analgesic properties used to relieve bladder pain and discomfort related to other conditions, has been investigated in a small study with encouraging result in this patient population. This suggest that PPS is well tolerated and effective at decreasing BCG-related LUTS. The purpose of this study is first to investigate the efficacy of co-administration of Pentosan Polysulphate to prevent these adverse events and the impact of this intervention on quality of life. The second goal is to determine which patients are more vulnerable to develop BCG- related lower urinary tract symptoms (LUTS), based on clinical assessment, demographics data, voiding parameters, and urinary inflammatory markers, and then to assess the effectiveness of BCG therapy following co-administration of ELMIRON.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Elmiron

Condition Name

Condition Name for Elmiron
Intervention Trials
Interstitial Cystitis 3
Schizophrenia 1
Bladder Carcinoma 1
Schizoaffective Disorder 1
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Condition MeSH

Condition MeSH for Elmiron
Intervention Trials
Cystitis, Interstitial 3
Cystitis 3
Psychotic Disorders 1
Mental Disorders 1
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Clinical Trial Locations for Elmiron

Trials by Country

Trials by Country for Elmiron
Location Trials
United States 35
Canada 7
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Trials by US State

Trials by US State for Elmiron
Location Trials
Ohio 2
Michigan 2
Illinois 2
California 2
Washington 2
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Clinical Trial Progress for Elmiron

Clinical Trial Phase

Clinical Trial Phase for Elmiron
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Elmiron
Clinical Trial Phase Trials
Terminated 2
Completed 2
Enrolling by invitation 1
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Clinical Trial Sponsors for Elmiron

Sponsor Name

Sponsor Name for Elmiron
Sponsor Trials
Cancer Research Network 1
The University of Texas Health Science Center, Houston 1
The Cleveland Clinic 1
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Sponsor Type

Sponsor Type for Elmiron
Sponsor Trials
Other 4
Industry 3
NIH 1
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