Trans GERD: Efficacy and Tolerability of Esomeprazol in P... | NCT00612027

Studies
Trans GERD: Efficacy and Tolerability of Esomeprazol in Patients Under Ordinary Medical Care Conditions

NCT00612027

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Feb 11, 2008Estimated

Enrollment

29,586Actual

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

ID	Type	Description	Link
German PMS trial no.9

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

Jan 2006

Primary Completion Date

Mar 2006Actual

Completion Date

Not provided

First Submitted Date

Jan 29, 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. general practitioners and internists) are asked to document relevant data related to esomeprazole therapy in patients with gastrointestinal disorders. Patients with acid associated gastrointestinal symptoms can be included.

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

29,586Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
efficacy and tolerability of esomeprazole in patients who are treated by general practitioners and internists		proportion of treated subjects without any specific acid associated symptoms at the end of the study; change in intensity of specific acid associated symptoms; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE.

Secondary Outcomes

Measure	Description	Time Frame
evaluation of a diagnosis tool		evaluation of the predictive value of a two items questionnaire on acid associated symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with gastrointestinal disorders and patients with acid associated gastrointestinal symptoms treated with esomeprazole.

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

general practitioners and internists

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