Retrospective Data Analysis in Crohn's Disease | NCT01363427

Studies
Retrospective Data Analysis in Crohn's Disease

NCT01363427

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Jun 1, 2011Estimated

Enrollment

161Actual

Phase

Not provided

Conditions

Crohn's Disease

Interventions

Not provided

Countries

Germany

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

May 2011

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

Mar 2007

Primary Completion Date

May 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

May 30, 2011

First Submission Date that Met QC Criteria

May 31, 2011

First Posted Date

Jun 1, 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

May 31, 2011

Last Update Posted Date

Jun 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.

Detailed Description

Not provided

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

161Actual

Label	Type	Description	Intervention Names
Crohn's disease		Patients with initially diagnosed Crohn's disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to Mesalazine: measured by time to step up therapy		12 to 48 months

Secondary Outcomes

Measure	Description	Time Frame
Identification and characterisation of the responding sub-population	measured by: (a) Age at diagnosis, (b) Proportion of patients with minor endoscopic lesions, (c) Lack of severe mucosal lesions (Adapted Rutgeerts Score < 2)	12 to 48 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

therapeutic need according to SPC
written informed consent

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

Private practices

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site, Ehrenfelsstraße 47		Berlin			Germany
Investigational Site, Möllendorfstraße 111

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided