Symptoms and Endoscopic Results in Consideration of Pretr... | NCT00612404

Studies
Symptoms and Endoscopic Results in Consideration of Pretreatment

NCT00612404

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Feb 11, 2008Estimated

Enrollment

16,255Actual

Phase

Not provided

Conditions

Gastrointestinal Diseases

Interventions

Not provided

Countries

Not provided

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

Jan 2008

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

Sep 2005

Primary Completion Date

Dec 2005Actual

Completion Date

Not provided

First Submitted Date

Jan 28, 2008

First Submission Date that Met QC Criteria

Feb 8, 2008

First Posted Date

Feb 11, 2008Estimated

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 8, 2008

Last Update Posted Date

Feb 11, 2008Estimated

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

Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e. gastroenterologists) are asked to document relevant data in patients with gastrointestinal disorders.

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

16,255Actual

Label	Type	Description	Intervention Names
1		patients with gastrointestinal disorders who need an endoscopy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to gain insight into the relationship between subjective gastrointestinal symptoms and findings of a laryngopharyngeal-esophagogastric endoscopy with respect to the medicinal pre-therapy;

Secondary Outcomes

Measure	Description	Time Frame
to gain insight into the currently used treatment strategies with esomeprazole depending on endoscopic findings.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with gastrointestinal disorders who need an endoscopy.

Exclusion Criteria:

limitiations; possible risks; warnings; contraindications mentioned in the SPC.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

gastroenterologists; specialists

Sampling Method

Probability Sample

Name	Affiliation	Role
Kai Richter, MD	Medical Department AstraZeneca Germany	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D005767	Gastrointestinal Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided