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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)

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)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00626535
Enrollment
500
Registered
2008-02-29
Start date
2003-03-31
Completion date
2004-02-29
Last updated
2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Gastroesophageal Reflux Disease (sGERD)

Keywords

Symptomatic Gastroesophageal Reflux Disease (sGERD), Nexium, Esomeprazole

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)

Interventions

DRUGEsomeprazole

20mg Oral Once Daily

DRUGMatching placebo

Oral Once Daily

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 sGERDDaily diary cards completed by the patient

Secondary

MeasureTime frame
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 sGERDDaily diary cards completed by the patient
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 sGERDPercentage of days without upper abdominal pain over the 4-week treatment period
To assess the safety and tolerability of esomeprazole 20 mg qd through 4 weeks of treatment.Mean severity of the patient's upper abdominal pain over the last 4 weeks.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026