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)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Symptomatic Gastroesophageal Reflux Disease (sGERD)

Treatments: Drug: Matching placebo; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626535

D9619C00001

Details and patient eligibility

About

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)

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

20mg once daily

Treatment:

Drug: Esomeprazole

2

Placebo Comparator group

Description:

Oral once daily

Treatment:

Drug: Matching placebo