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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00451867
Other study ID # DK765209-Cellcept (IND)
Secondary ID
Status Terminated
Phase Phase 3
First received March 23, 2007
Last updated January 12, 2010
Start date March 2007
Est. completion date April 2008

Study information

Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Description:

Interstitial Cystitis (IC) is a bladder syndrome characterized as painful, debilitating and chronic, with no universally successful treatment option currently available. Characteristic symptoms include pain with bladder filling, and marked urinary frequency (to relieve pain). The only FDA-approved oral medication for treatment of IC is pentosan polysulfate (Elmiron), recently demonstrated by our collaborative research network to perform with little more efficacy than placebo (ref), and which is expensive and has associated side effects. Current clinical treatment protocols are empiric and usually aimed at relieving pain. There is a pressing need for an effective oral medication for treatment of IC. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Mycophenolate Mofetil

Mycofenolate Mofetil (MMF)
2000 mg per day divided into 2 equal doses.
Placebo
Placebo

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Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare CellCept 2 grams daily to placebo for effects on overall IC symptoms and well being in patients with refractory PBS/IC. 12 Weeks Yes
Primary To assess the safety profile of CellCept in the treatment of refractory PBS/IC. 12 Weeks Yes
Secondary To investigate the association between clinical subgroups, characterized by differences in baseline characteristics (such as presence of ulcers, duration of symptoms, significant co-morbid diseases, serological abnormalities), and efficacy of CellCept. 12 Weeks No
Secondary To assess the patterns of patient expectations, associations with symptom severity, and the potential impact of patient expectations on response to treatment. 12 Weeks No
Secondary To assess patterns of treatment goals and goal achievement in this study population, as well as baseline characteristics and factors related to goal selection and achievement. 12 Weeks No
Secondary To assess impact of study medication on pain medication use. 12 Weeks No
Secondary To assess the frequency and mechanism of un-blinding on study results and assess how the patient's perception of which treatment they received changes over time and influences ultimate outcome. 12 Weeks No
Secondary To assess the rate of detectable immune disorders in patients with PBS/IC refractory to standard treatment using CellCept. 12 Weeks No
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