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

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

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1	Drug: Esomeprazole 20mg Oral tablet once daily Other Name: Nexium
Experimental: 2	Drug: Esomeprazole 40mg Oral tablet once daily Other Name: Nexium
Placebo Comparator: 3	Drug: Placebo Oral once daily

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=688&filename=CSR-D961AC00001.pdf
Download
CSR-D961AC00001.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

null AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

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)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=688&filename=CSR-D961AC00001.pdf

CSR-D961AC00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator