Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660660
First received: April 15, 2008
Last updated: March 10, 2009
Last verified: March 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Esomeprazole
20mg once daily
Other Name: Nexium
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Tore Lind - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00660660     History of Changes
Other Study ID Numbers: D9612L00122
Study First Received: April 15, 2008
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
GERD
Esophageal Reflux
Gastro-Esophageal Reflux
Regurgitation
Gastric

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014