A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients with Heartburn and Sleep Disturbances Associated with Gastroesophageal Reflux Disease (GERD)

Study identifier:D961AC00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients with Heartburn and Sleep Disturbances Associated with Gastroesophageal Reflux Disease (GERD)

Medical condition

Gastroesophageal reflux disease (GERD)

Phase

Phase 4

Healthy volunteers

No

Study drug

Esomeprazole, Placebo

Sex

All

Actual Enrollment

600

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 01 Apr 2003
Primary Completion Date: 01 Aug 2003
Study Completion Date: 01 Aug 2003

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria