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)

This study has been completed.

First Received: February 21, 2008 Last Updated: March 11, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00626535

Purpose

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)

Condition	Intervention	Phase
Symptomatic Gastroesophageal Reflux Disease (sGERD)	Drug: Esomeprazole Drug: Matching placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]
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 ]
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. ]

Estimated Enrollment:	500
Study Start Date:	March 2003
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 20mg once daily	Drug: Esomeprazole 20mg Oral Once Daily
2: Placebo Comparator Oral once daily	Drug: Matching placebo Oral Once Daily

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626535

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	D9619C00001
Study First Received:	February 21, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00626535 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Symptomatic Gastroesophageal Reflux Disease (sGERD)
Nexium
Esomeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Abdominal Pain
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pain
Gastroesophageal Reflux

Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Signs and Symptoms
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on February 08, 2010