Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00660660

Purpose

The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Esomeprazole Drug: Placebo	Phase IV

MedlinePlus related topics: Esophagus Disorders GERD Heartburn Sleep Disorders

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To demonstrate a difference in the relief of nighttime heartburn between esomeprazole 20 mg qd and placebo qd in patients with GERD as measured by a daily diary card [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the impact of treatment with Esomeprazole 20mg versus placebo on sleep disturbances associated with GERD [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	April 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Esomeprazole 20mg once daily
2: Placebo Comparator	Drug: Placebo once daily

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;
Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;
Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;

Exclusion Criteria:

Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance
Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. Patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation;
Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable acid modifying rescue medication is GELUSIL® during the run-in period. Only study medication and rescue medication (GELUSIL®) is allowed during the treatment period for treatment of acid mediated symptoms

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660660

Show 45 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tore Lind, MD	AstraZeneca
Study Director:	Kurt Brown, MD	AstraZeneca
Principal Investigator:	David Johnson, MD	Eastern Virginia Medical School

More Information

Responsible Party:	AstraZeneca ( Tore Lind - Medical Science Director )
Study ID Numbers:	D9612L00122
Study First Received:	April 15, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00660660
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

GERD
Esophageal Reflux
Gastro-Esophageal Reflux
Regurgitation
Gastric

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Heartburn
Omeprazole
Dyssomnias
Sleep Disorders
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009