Back to resultsA Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Primary Purpose
Symptomatic Gastroesophageal Reflux Disease (sGERD)
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esomeprazole
Matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Gastroesophageal Reflux Disease (sGERD) focused on measuring Symptomatic Gastroesophageal Reflux Disease (sGERD), Nexium, Esomeprazole
Eligibility Criteria
Inclusion Criteria:
- History of episodes of heartburn and upper abdominal pain for 6 months or longer.
- Episodes of heartburn 2 or more days during the 7 days prior to the screening visit. Moderate or severe upper abdominal pain on at least 3 out of the 7 consecutive days of the run-in period.
- A normal endoscopy within 14 days of Visit 1 of between Run-in and randomization.
Exclusion Criteria:
- Subjects with pain likely to be due to irritable bowel syndrome (IBS)
- History of esophageal, gastric or duodenal surgery, except for closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Further diseases / conditions, as listed in the protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
20mg once daily
Oral once daily
Outcomes
Primary Outcome Measures
To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 4 weeks of treatment in patients with sGERD
Secondary Outcome Measures
To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 1, 2, and 4 weeks of treatment in patients with sGERD
To demonstrate a difference in percentage of days with, days to resolution of, and severity of upper abdominal pain through 4 weeks of treatment between esomeprazole 20 mg once daily and placebo qd in patients with sGERD
To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00626535
Brief Title
A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Official Title
A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study compares 4 weeks of treatment with Esomeprazole 20 mg once daily to Placebo in the treatment of Upper Abdominal Pain in patients with Symptomatic Gastroesophageal Reflux Disease (sGERD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Gastroesophageal Reflux Disease (sGERD)
Keywords
Symptomatic Gastroesophageal Reflux Disease (sGERD), Nexium, Esomeprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
20mg once daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oral once daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg Oral Once Daily
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
Oral Once Daily
Primary Outcome Measure Information:
Title
To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 4 weeks of treatment in patients with sGERD
Time Frame
Daily diary cards completed by the patient
Secondary Outcome Measure Information:
Title
To demonstrate a difference between esomeprazole 20 mg once daily and placebo qd in the resolution and relief of upper abdominal pain after 1, 2, and 4 weeks of treatment in patients with sGERD
Time Frame
Daily diary cards completed by the patient
Title
To demonstrate a difference in percentage of days with, days to resolution of, and severity of upper abdominal pain through 4 weeks of treatment between esomeprazole 20 mg once daily and placebo qd in patients with sGERD
Time Frame
Percentage of days without upper abdominal pain over the 4-week treatment period
Title
To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment.
Time Frame
Mean severity of the patient's upper abdominal pain over the last 4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of episodes of heartburn and upper abdominal pain for 6 months or longer.
Episodes of heartburn 2 or more days during the 7 days prior to the screening visit. Moderate or severe upper abdominal pain on at least 3 out of the 7 consecutive days of the run-in period.
A normal endoscopy within 14 days of Visit 1 of between Run-in and randomization.
Exclusion Criteria:
Subjects with pain likely to be due to irritable bowel syndrome (IBS)
History of esophageal, gastric or duodenal surgery, except for closure of an ulcer.
History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
Further 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
Learn more about this trial
A Multicenter, Randomized, Double-Blind Parallel-Group, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg Once Daily to Placebo qd for the Resolution of Upper Abdominal Pain in Patients With Symptomatic Gastroesophageal Reflux Disease (sGERD)
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