Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00635414

Purpose

This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)

Condition	Intervention	Phase
GERD	Drug: Esomeprazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	An Open, Randomized, Two-Way Crossover Study Comparing the Effect of 40mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD).

Resource links provided by NLM:

MedlinePlus related topics: 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:

The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods. [ Time Frame: MAO will be assessed after 10 days of treatment (Day 11 or Day 20) ]

Secondary Outcome Measures:

Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20) [ Time Frame: BAO will be assessed after 10 days of treatment ]
To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing. [ Time Frame: Assessments at Day 2 and after Day 10 (Day 11 or Day 20) ]
To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD. [ Time Frame: Safety assessments throughout the study ]

Estimated Enrollment:	60
Study Start Date:	August 2002
Study Completion Date:	October 2002
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 40mg administered orally	Drug: Esomeprazole 40mg oral
2: Experimental 15 minute intravenous infusion	Drug: Esomeprazole 15 minute intravenous infusion

Eligibility

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

Criteria

Inclusion Criteria:

Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the following formula: weight (kg)/height (m)2.]
Able to communicate with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
Abnormal lab test results, as indicated in the protocol.
Other diseases, as indicated in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635414

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Study ID Numbers:	SH-NEP-0011, D9615C00011
Study First Received:	March 6, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00635414 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on September 10, 2009