Gastroesophageal Reflux DiseasePhase 4NCT00660660
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
A Phase 4 study testing Esomeprazole in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 45 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Esomeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 45 sitesUnited States
- Study dates
- Apr 2008to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Research Site
Albuquerque, New Mexico
Research Site
Amarillo, Texas
Research Site
Anaheim, California
Research Site
Bellevue, Washington
Research Site
Binghamton, New York
Research Site
Boynton Beach, Florida
Research Site
Burbank, California
Research Site
Burke, Virginia
Research Site
Castro Valley, California
Research Site
Chattanooga, Tennessee
Research Site
Christiansburg, Virginia
Research Site
Cincinnati, Ohio
Research Site
Coral Springs, Florida
Research Site
Dayton, Ohio
Research Site
DeLand, Florida
Research Site
Fort Worth Dallas, Texas
Research Site
Fredericksburg, Virginia
Research Site
Hollywood, Florida
Research Site
Hollywood, Maryland
Research Site
Houston, Texas
Research Site
Huntersville, North Carolina
Research Site
Huntsville, Alabama
Research Site
Johnson City, Tennessee
Research Site
Jupiter, Florida
Research Site
Kettering, Ohio
Research Site
Las Vegas, Nevada
Research Site
Lexington, Kentucky
Research Site
Little Rock, Arkansas
Research Site
Medford, New Jersey
Research Site
Newport News, Virginia
Research Site
Ogden, Utah
Research Site
Oklahoma City, Oklahoma
Research Site
Orange, California
Research Site
Overland Park, Kansas
Research Site
Pembroke Pines, Florida
Research Site
Perth Amboy, New Jersey
Research Site
Raleigh, North Carolina
Research Site
San Diego, California
Research Site
South Miami, Florida
Research Site
Stockbridge, Georgia
Research Site
Tampa, Florida
Research Site
Tucson, Arizona
Research Site
West Orange, New Jersey
Research Site
Winston-Salem, North Carolina
Research Site
Zephyrhills, Florida
About this 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)
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).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Esomeprazole, Placebo
- Keywords
- GERD, Esophageal Reflux, Gastro-Esophageal Reflux, Regurgitation, Gastric
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
PlaceboDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Nexium 20mg | Experimental | Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate Receives: Drug: Esomeprazole |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of 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).
Measured: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Secondary outcomes (46)
Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline
To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, "no difficulty" to 3, "severe difficulty." Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.
Measured: Baseline and 4 weeks
Achievement of Developer-defined Good Sleep
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal reflux disease (GERD), as measured by achievement of (yes/no) developer-defined good sleep (global Pittsburgh Sleep Quality Index - PSQI score ≤5) at Week 4.
Measured: 4 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 7 consecutive days.
Measured: 1 week
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 14 consecutive days.
Measured: 2 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?". Complete resolution of Gastroesophageal Reflux Disease (GERD)-related sleep disturbances was defined as a daily diary response of "No" on 7 consecutive days during 4 weeks of treatment.
Measured: 4 weeks
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.
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Complete resolution of sleep disturbances on the patient's last 7 days in the study.
Measured: 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 1 Week of Treatment
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.
Measured: 1 week
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.
Measured: 2 weeks
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.
Measured: 4 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.
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.
Measured: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)as measured by: Percent of days without sleep disturbances after 4 weeks of treatment. Each morning of the study, patients registered their answer "Yes" or "No" to the question, "Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?" in the diary card.'
Measured: 4 weeks
Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days, and 'days to first relief' was defined as the first day of the 7 days that reached relief of sleep disturbance.
Measured: 4 weeks
Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.
Measured: 4 weeks
Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Days to complete resolution of sleep disturbance. Days to complete resolution of sleep disturbances associated with GERD was defined as the number of days until the first day of the first 7-consecutive-day period during which the patient's daily diary response was "No" (did not have trouble sleeping due to GERD symptoms).'
Measured: 4 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 1 week of treatment. Results based on MITT population with available data for this outcome measure. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 1 week
Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 2 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 4 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 1 week
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 2 weeks
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 4 weeks
Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 1 week
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 2 weeks
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: 4 weeks
Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.
Measured: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Results based on MITT population with available data for this outcome measure. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'
Measured: 1 week
Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'
Measured: 2 weeks
Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'
Measured: 4 weeks
Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'
Measured: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 1 week
Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 2 weeks
Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 4 weeks
Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 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
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 1 week
Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 2 weeks
Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 4 weeks
Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study
To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.
Measured: 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
Number and percentage of patients with nighttime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.
Measured: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study
Number of patients with daytime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.
Measured: Days 21-28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.
Number of patients with 24-hour heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.
Measured: 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)
Measured: 4 weeks
Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)
Degree of sleep disturbance affecting work productivity. 100% is considered to be the worst outcome where there is no ability to work. 0% is considered to be the best outcome, no impairment.
Measured: Baseline and 4 weeks
Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)
Equivalent number of work hours missed was derived from questions 2, 4 and 5 of the Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (Gastroesophageal Reflux Disease) and summed up with the percent work impairment during the remaining hours that were actually worked.
Measured: Baseline and 4 weeks
Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)
To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, "no difficulty" to 3, "severe difficulty." Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.
Measured: Baseline and 4 weeks
Monetary Value of Work Hours Saved
The monetary value of the work hours saved was derived from questions 2,4, and 5 of the WPAI and a standard hourly compensation rate reported by the US Bureau of Labor Statistics (US$28.48 as of June 2008).
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tore Lind, MD, Study director, AstraZenecaKurt Brown, MD, Study director, AstraZenecaDavid Johnson, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660660
- Sponsor's protocol ID
- D9612L00122
- Status last verified
- Feb 2015
- First submitted
- 15 Apr 2008
- Last updated
- 2 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25478944
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00660660
- Acronym / sponsor ID
- D9612L00122
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Esophageal Reflux, Gastro-Esophageal Reflux, Regurgitation, Gastric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Posted 2 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nexium 20mg | Experimental | Drug: EsomeprazoleNexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsomeprazoleAlso: NexiumNexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate | Drug | Nexium 20mg |
| Placeboonce daily | Drug | Placebo |
Primary outcome
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).
46 secondary outcomes
Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline
Time frame: Baseline and 4 weeks
Achievement of Developer-defined Good Sleep
Time frame: 4 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.
Time frame: 1 week
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.
Time frame: 2 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.
Time frame: 4 weeks
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.
Time frame: 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 1 Week of Treatment
Time frame: 1 week
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment
Time frame: 2 weeks
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment
Time frame: 4 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.
Time frame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period
Time frame: 4 weeks
Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
Time frame: 4 weeks
Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
Time frame: 4 weeks
Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period
Time frame: 4 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment
Time frame: 1 week
Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment
Time frame: 2 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment
Time frame: 4 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study
Time frame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.
Time frame: 1 week
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment
Time frame: 2 weeks
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment
Time frame: 4 weeks
Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.
Time frame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment
Time frame: 1 week
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment
Time frame: 2 weeks
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment
Time frame: 4 weeks
Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study
Time frame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment
Time frame: 1 week
Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment
Time frame: 2 weeks
Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment
Time frame: 4 weeks
Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study
Time frame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.
Time frame: 1 week
Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment
Time frame: 2 weeks
Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment
Time frame: 4 weeks
Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study
Time frame: 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
Time frame: 1 week
Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment
Time frame: 2 weeks
Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment
Time frame: 4 weeks
Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study
Time frame: 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
Time frame: Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study
Time frame: Days 21-28 (for early dropouts the last 7 days staying in the study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25478944Johnson 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.
- Related InfoLink provided by the sponsor.
- CSR-D9612L00122.pdfLink provided by the sponsor.
Related trials for Gastroesophageal Reflux Disease
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tore Lind, MD study director
AstraZeneca
Kurt Brown, MD study director
AstraZeneca
David Johnson, MD principal investigator
Eastern Virginia Medical School
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00660660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.