An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg 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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2002-10-31

Brief Summary

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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)

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Detailed Description

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Conditions

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GERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

20mg oral

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

20mg oral

2

15 minute intravenous infusion

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

15 minute intravenous infusion

Interventions

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Esomeprazole

20mg oral

Intervention Type DRUG

Esomeprazole

15 minute intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Nexium Nexium

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. \[BMI will be calculated using the following formula: weight (kg)/height (m)2.\]
3. Able to communicate with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria

1. History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. 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.
4. Abnormal lab test results, as indicated in the protocol.
5. Other diseases, as indicated in the protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No