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)
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Symptomatic Gastroesophageal Reflux Disease (sGERD)
Intervention: Esomeprazole (Drug); Matching placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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)
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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: 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 sGERDTo 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: March 2003
Last updated: March 11, 2009
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