A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Gastroesophageal Reflux Disease (GERD)
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal Reflux Disease, GERD, Esomeprazole, Heartburn, Nexium
Eligibility Criteria
Inclusion Criteria:
- A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis.
- Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more.
- Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period..
Exclusion Criteria:
- Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance.
- Shift workers who work between 12am (midnight) and 6am.
- Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study.
- Other diseases / conditions as listed in the protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Daily patient diary cards to demonstrate whether there is a difference in the relief of nighttime heartburn between esomeprazole 20 mg once daily (E20), and placebo once daily and between esomeprazole 40 mg once daily (E40) in patients with GERD.
Secondary Outcome Measures
To assess the impact of treatment with E20 versus placebo and E40 versus placebo on sleep disturbances associated with GERD as measured by:Change in global PSQI score; Complete resolution of sleep disturbances; Relief of sleep disturbances; Perc
To assess the impact of treatment with E20 versus placebo and E40 versus placebo on heartburn as measured by:Complete resolution of daytime heartburn; Complete resolution of nightime heartburn; Relief of daytime heartburn; Improvement in the fre
To quantify the difference during 4 weeks of treatment between E20 and E40 in patients with GERD as measured by: - Relief of nightime heartburn - Relief of sleep disturbances associated with GERD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00628342
Brief Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
Gastroesophageal Reflux Disease, GERD, Esomeprazole, Heartburn, Nexium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg Oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40mg Oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral once daily
Primary Outcome Measure Information:
Title
Daily patient diary cards to demonstrate whether there is a difference in the relief of nighttime heartburn between esomeprazole 20 mg once daily (E20), and placebo once daily and between esomeprazole 40 mg once daily (E40) in patients with GERD.
Time Frame
Daily diary cards completed by the patients.
Secondary Outcome Measure Information:
Title
To assess the impact of treatment with E20 versus placebo and E40 versus placebo on sleep disturbances associated with GERD as measured by:Change in global PSQI score; Complete resolution of sleep disturbances; Relief of sleep disturbances; Perc
Time Frame
Daily diary cards completed by the patients
Title
To assess the impact of treatment with E20 versus placebo and E40 versus placebo on heartburn as measured by:Complete resolution of daytime heartburn; Complete resolution of nightime heartburn; Relief of daytime heartburn; Improvement in the fre
Time Frame
Daily diary cards completed by the patients.
Title
To quantify the difference during 4 weeks of treatment between E20 and E40 in patients with GERD as measured by: - Relief of nightime heartburn - Relief of sleep disturbances associated with GERD
Time Frame
Daily diary cards completed by the patients.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis.
Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more.
Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period..
Exclusion Criteria:
Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance.
Shift workers who work between 12am (midnight) and 6am.
Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study.
Other diseases / conditions as listed in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
25478944
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.
Results Reference
derived
Learn more about this trial
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
We'll reach out to this number within 24 hrs