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)

March 11, 2009 updated by: AstraZeneca
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
20mg once daily
Drug: Esomeprazole
20mg Oral Once Daily
Other Names:
  • Nexium
Placebo Comparator: 2
Oral once daily
Drug: Matching placebo
Oral Once Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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 sGERD
Time Frame: Daily diary cards completed by the patient
Daily diary cards completed by the patient

Secondary Outcome Measures

Outcome Measure
Time 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 sGERD
Time Frame: Daily diary cards completed by the patient
Daily 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 sGERD
Time Frame: Percentage of days without upper abdominal pain over the 4-week treatment period
Percentage 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.
Time Frame: Mean severity of the patient's upper abdominal pain over the last 4 weeks.
Mean severity of the patient's upper abdominal pain over the last 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 29, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9619C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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