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)

Symptomatic Gastroesophageal Reflux Disease (sGERD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626535
• Other study ID #: D9619C00001
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2008
• Last updated: March 11, 2009
• Start date: March 2003
• Est. completion date: February 2004

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Gastroesophageal Reflux
• Symptomatic Gastroesophageal Reflux Disease (sGERD)

Intervention

Drug:
• Esomeprazole
20mg Oral Once Daily
• Matching placebo
Oral Once Daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Daily diary cards completed by the patient
Secondary	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		Daily diary cards completed by the patient
Secondary	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		Percentage of days without upper abdominal pain over the 4-week treatment period
Secondary	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.