Phase 4
N=276
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT00660660 ↗Enrolled (actual)
276
Serious AEs
0.4%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study. — 34.3; 10.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Esomeprazole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study. |
34.3; 10.4 | — |
| SECONDARY Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline |
-2.93; -1.80 | — |
| SECONDARY Achievement of Developer-defined Good Sleep |
19; 24 | — |
| SECONDARY Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment. |
44; 23 | — |
| SECONDARY Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment. |
54; 20 | — |
| SECONDARY Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment. |
29; 14 | — |
| SECONDARY 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. |
66; 27 | — |
| SECONDARY Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment |
79; 53 | — |
| SECONDARY Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment |
90; 54 | — |
| SECONDARY Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment |
74; 45 | — |
| SECONDARY Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study. |
71.5; 55.2 | — |
| SECONDARY Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period |
73.0; 59.3 | — |
| SECONDARY Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period |
1; 3 | — |
| SECONDARY Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period |
1; 2 | — |
| SECONDARY Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period |
9; 21 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment |
22; 4 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment |
37; 11 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment |
35; 7 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study |
45; 9 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment. |
23; 4 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment |
36; 6 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment |
25; 6 | — |
| SECONDARY Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study. |
42; 8 | — |
| SECONDARY Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment |
16; 3 | — |
| SECONDARY Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment |
30; 4 | — |
| SECONDARY Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment |
30; 4 | — |
| SECONDARY Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study |
37; 5 | — |
| SECONDARY Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment |
34; 13 | — |
| SECONDARY Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment |
48; 14 | — |
| SECONDARY Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment |
40; 9 | — |
| SECONDARY Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study |
55; 14 | — |
| SECONDARY Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment. |
28; 9 | — |
| SECONDARY Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment |
40; 7 | — |
| SECONDARY Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment |
26; 6 | — |
| SECONDARY Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study |
47; 13 | — |
| SECONDARY Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment |
27; 5 | — |
| SECONDARY Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment |
36; 5 | — |
| SECONDARY Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment |
33; 5 | — |
| SECONDARY Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study |
45; 9 | — |
| SECONDARY Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study |
89.8; 83.2 | — |
| SECONDARY Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study |
86.1; 76 | — |
| SECONDARY Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study. |
89.8; 80 | — |
| SECONDARY Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average) |
8.9; 5.2 | — |
| SECONDARY Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average) |
-25.3; -14 | — |
| SECONDARY Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average) |
-24.8; -14.9 | — |
| SECONDARY Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average) |
-25.1; -17.1 | — |
| SECONDARY Monetary Value of Work Hours Saved |
280.21; 156.61 | — |
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
Data sourced from ClinicalTrials.gov (NCT00660660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.