Clinical trial NCT00660660: Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Esophageal Reflux
Gastro-Esophageal Reflux
Regurgitation
Gastric
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Secondary outcomes:
measure: Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline
timeFrame: Baseline and 4 weeks
measure: Achievement of Developer-defined Good Sleep
timeFrame: 4 weeks
measure: Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.
timeFrame: 1 week
measure: Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.
timeFrame: 2 weeks
measure: Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.
timeFrame: 4 weeks
measure: 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.
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment
timeFrame: 1 week
measure: Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period
timeFrame: 4 weeks
measure: Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
timeFrame: 4 weeks
measure: Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
timeFrame: 4 weeks
measure: Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
timeFrame: 4 weeks
measure: Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment
timeFrame: 1 week
measure: Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.
timeFrame: 1 week
measure: Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment
timeFrame: 1 week
measure: Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment
timeFrame: 1 week
measure: Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.
timeFrame: 1 week
measure: Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment
timeFrame: 1 week
measure: Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment
timeFrame: 2 weeks
measure: Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study
timeFrame: Days 21-28 (for early dropouts the last 7 days staying in the study)
measure: Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.
timeFrame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
measure: Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)
timeFrame: 4 weeks
measure: Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)
timeFrame: Baseline and 4 weeks
measure: Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)
timeFrame: Baseline and 4 weeks
measure: Monetary Value of Work Hours Saved
timeFrame: Week 4
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Burbank
country: United States
facility: Research Site
state: California
city: Castro Valley
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Coral SPrings
country: United States
facility: Research Site
state: Florida
city: Deland
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Jupiter
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: South Miami
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Zephyrhills
country: United States
facility: Research Site
state: Florida
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Hollywood
country: United States
facility: Research Site
state: Maryland
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Medford
country: United States
facility: Research Site
state: New Jersey
city: Perth Amboy
country: United States
facility: Research Site
state: New Jersey
city: West Orange
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Binghamton
country: United States
facility: Research Site
state: New York
city: Huntersville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Kettering
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Johnson City
country: United States
facility: Research Site
state: Tennessee
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Fort Worth Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Burke
country: United States
facility: Research Site
state: Virginia
city: Christiansburg
country: United States
facility: Research Site
state: Virginia
city: Fredericksburg
country: United States
facility: Research Site
state: Virginia
city: Newport News
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: AstraZeneca
name: Tore Lind, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Kurt Brown, MD
role: STUDY_DIRECTOR
affiliation: Eastern Virginia Medical School
name: David Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson DA, Le Moigne A, Hugo V, Nagy P. Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials. Curr Med Res Opin. 2015 Feb;31(2):243-50. doi: 10.1185/03007995.2014.991818. Epub 2015 Jan 9.