Symptom adapted therapy in GERD patients - SYMPATHY

Study identifier:D9612L00109

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, open, parallel-group, multi-national, multi-centre, phase IV study to evaluate the efficacy of three different patient management strategies with and without esomeprazole 20 mg during a 3 months maintenance phase following an initial 4-weeks acute treatment phase in subjects with symptoms thought to be GERD related

Medical condition

Gastroesophageal Reflux Disease (GERD).

Phase

Phase 4

Healthy volunteers

No

Study drug

esomeprazole, Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Sex

All

Actual Enrollment

441

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Aug 2006
Primary Completion Date: 01 Aug 2007
Study Completion Date: 01 Aug 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria