Exacerbating Factors in Inflammatory Bowel Disease | NCT01405105

Studies
Exacerbating Factors in Inflammatory Bowel Disease

NCT01405105

Sponsor

Dallas VA Medical Center

Status

Completed

Last Update Posted

Feb 14, 2014Estimated

Enrollment

134Actual

Phase

Not provided

Conditions

Ulcerative Colitis
Crohn's Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jul 28, 2011

First Submission Date that Met QC Criteria

Jul 28, 2011

First Posted Date

Jul 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2014

Last Update Posted Date

Feb 14, 2014Estimated

Name	Class
Centocor Ortho Biotech Services, L.L.C.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.

Detailed Description

Detailed questionnaires with patient in regards to potential triggers for flares of IBD. Includes both patients with flares and those in remission as a control group.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Flares of IBD		Active flare of Crohn's or UC
Control Group		Patients with quiescent Crohn's disease or UC

Interventions

Not provided

Measure	Description	Time Frame
Frequency of identifiable trigger for flare		baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of verified Crohn's disease or ulcerative colitis

Exclusion Criteria:

unwilling to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Flare of Crohn's disease Flare of ulcerative colitis Quiescent IBD (control)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linda A Feagins, MD	Dallas VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dallas VA Medical Center		Dallas	Texas	75216	United States

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D003424	Crohn Disease

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided