Events Preceding Interstitial Cystitis (EPIC) (EPIC)

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ClinicalTrials.gov Identifier: NCT00248664

Recruitment Status : Completed

First Posted : November 4, 2005

Last Update Posted : March 3, 2010

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information

First Submitted Date

November 3, 2005

First Posted Date

November 4, 2005

Last Update Posted Date

March 3, 2010

Study Start Date

March 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures

Not Provided

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Events Preceding Interstitial Cystitis (EPIC)

Official Title

A Case Control Study of Interstitial Cystitis

Brief Summary

EPIC is a case/control study that seeks to identify the risk factors for interstitial cystitis by comparing the experiences and medical histories of 400 women who recently developed IC with 400 similar people who do not have the disease.

Detailed Description

This project is a systematic, national study of incident IC cases and controls matched by age and gender. By telephone interview and medical record review, we compare exposures of cases and controls seeking significant differences which may be risk factors for IC. This cohort of incident IC cases will initiate a natural history study of the disease.

Specific Aim 1. To test the hypothesis that certain features that precede onset of IC symptoms, e.g., bacterial cystitis, distinguish IC cases from controls matched for age and gender, and may be risk factors for the disease.

Specific Aim 2. To test the hypotheses that patients with IC have higher prevalences of certain non bladder syndromes, e.g., irritable bowel syndrome, than do controls matched for age and gender.

Specific Aim 3. To test the hypothesis that urine APF, HB EGF, and/or EGF are sensitive and specific diagnostic markers for IC in patients with symptoms of ÿ12 months.

Specific Aim 4. To test the hypotheses that, in an incident cohort, patients with IC have remissions and that certain clinical features, e.g., bacterial cystitis at disease onset, are prognostic factors for remissions.

Study Type

Observational

Study Design

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition

Cystitis, Interstitial

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Estimated Enrollment

400

Original Enrollment

Same as current

Actual Study Completion Date

November 2008

Primary Completion Date

Not Provided

Eligibility Criteria

Inclusion Criteria: Female Adults(18 and over) who have had symotoms of IC for 12 months or fewer

Exclusion Criteria: Males,children, those who do not have symptoms of IC or those who have had symtoms for greater than 12 months.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT00248664

Other Study ID Numbers

DK64880 (completed)

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

John W Warren, MD

University of Maryland School of Medicine

PRS Account

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

March 2010

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