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History of Changes for Study: NCT00248664
Events Preceding Interstitial Cystitis (EPIC)
Latest version (submitted March 2, 2010) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 3, 2005 None (earliest Version on record)
2 May 10, 2006 Study Status
3 November 1, 2006 Study Status
4 May 1, 2007 Study Status and Study Design
5 November 26, 2007 Study Status and Study Design
6 November 5, 2008 Recruitment Status, Study Status, Contacts/Locations and Study Identification
7 March 2, 2010 Study Status and Study Identification
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Study NCT00248664
Submitted Date:  November 3, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: DK64880
Brief Title: Events Preceding Interstitial Cystitis (EPIC)
Official Title: A Case Control Study of Interstitial Cystitis
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2005
Overall Status: Recruiting
Study Start: March 2004
Primary Completion:
Study Completion: June 2008
First Submitted: November 3, 2005
First Submitted that
Met QC Criteria:
November 3, 2005
First Posted: November 4, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 3, 2005
Last Update Posted: November 4, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Cystitis, Interstitial
Keywords: Cystitis, Interstitial
Case-Control Studies
Risk Factors
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Other
Biospecimen Retention:
Biospecimen Description:
Enrollment: 400
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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

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

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Open or close this module Contacts/Locations
Central Contact Person: Linda Horne, AA
Telephone: 1-877-STUDYIC
Email: studyic@medicine.umaryland.edu
Central Contact Backup: Patty Greenberg, MA
Telephone: 1-877-STUDYIC
Email: studyic@medicine.umaryland.edu
Study Officials: John W Warren, MD
Principal Investigator
University of Maryland School of Medicine
Locations: United States, Maryland
University of Maryland School of Medicine
[Recruiting]
Baltimore, Maryland, United States, 21201
Contact:Contact: Linda Horne, AA 877-788-3942 studyic@medicine.umaryland.edu
Contact:Contact: Patty Greenberg, MA 1-877-788-3942 studyic@medicine.umaryland.edu
Contact:Principal Investigator: John W Warren, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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