Trial | NCT00343161  Report issue

Title

Symptom Adapted Therapy in GERD Patients
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    441
The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.
Study Started
Aug 31
2006
Primary Completion
Aug 31
2007
Study Completion
Aug 31
2007
Last Update
Jan 24
2011
Estimate

Drug esomeprazole

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

Criteria 

Inclusion Criteria:

Signed informed consent
Patients who seek medical advice in primary care for symptoms thought to be GERD-related

Exclusion Criteria:

Clinical GERD diagnosis/treatment within last 3 month
History of severe esophagitis (i.e. LA grade C or D)
Previous anti-reflux surgery
History of drug abuse
Female patients who are pregnant or lactating or at risk of pregnancy
No Results Posted