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)

AstraZeneca1 site in 1 country276 target enrollmentApril 2008

ConditionsGastroesophageal Reflux Disease

InterventionsEsomeprazole Placebo

DrugsEsomeprazole Placebo

Overview

Phase: Phase 4
Intervention: Esomeprazole
Conditions: Gastroesophageal Reflux Disease
Sponsor: AstraZeneca
Enrollment: 276
Locations: 1
Primary Endpoint: Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

July 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Nexium 20mg

Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate

Intervention: Esomeprazole

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.

Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study)

Relief of nighttime heartburn on patient's last 7 days in the study. Relief was defined as a daily diary card response of "none" or 0, on at least 6 of 7 days, allowing for one "mild" or 1 response. Diary card scale (none, mild, moderate, severe).

Secondary Outcomes

Achievement of Developer-defined Good Sleep(4 weeks)
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.(1 week)
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.(4 weeks)
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment(4 weeks)
Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period(4 weeks)
Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment(1 week)
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment(1 week)
Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period(4 weeks)
Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment(4 weeks)
Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline(Baseline and 4 weeks)
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.(2 weeks)
Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period(4 weeks)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.(1 week)
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment(2 weeks)
Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period(4 weeks)
Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.(1 week)
Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment(2 weeks)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment(2 weeks)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment(4 weeks)
Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment(2 weeks)
Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment(4 weeks)
Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment(4 weeks)
Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study(Days 21-28 (for early dropouts the last 7 days staying in the study))
Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)(4 weeks)
Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)(Baseline and 4 weeks)
Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)(Baseline and 4 weeks)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment(2 weeks)
Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment(1 week)
Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment(2 weeks)
Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment(2 weeks)
Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment(4 weeks)
Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment(1 week)
Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment(4 weeks)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment(1 week)
Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study(Days 21- 28 (for early dropouts the last 7 days staying in the study))
Monetary Value of Work Hours Saved(Week 4)
Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)(Baseline and 4 weeks)