Clinical trial NCT00626535: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)
Keywords: Symptomatic Gastroesophageal Reflux Disease (sGERD)
Nexium
Esomeprazole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: 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
timeFrame: Daily diary cards completed by the patient
Secondary outcomes:
measure: 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
timeFrame: Daily diary cards completed by the patient
measure: 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
timeFrame: Percentage of days without upper abdominal pain over the 4-week treatment period
measure: To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment.
timeFrame: Mean severity of the patient's upper abdominal pain over the last 4 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References: