Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously

January 24, 2011 updated by: AstraZeneca

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).

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

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:

  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.

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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
40mg administered orally
Drug: Esomeprazole
40mg oral
Other Names:
  • Nexium
Drug: Esomeprazole
15 minute intravenous infusion
Other Names:
  • Nexium
EXPERIMENTAL: 2
15 minute intravenous infusion
Drug: Esomeprazole
40mg oral
Other Names:
  • Nexium
Drug: Esomeprazole
15 minute intravenous infusion
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
MAO will be assessed after 10 days of treatment (Day 11 or Day 20)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
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
Safety assessments throughout the study

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

August 1, 2002

Primary Completion (ACTUAL)

October 1, 2002

Study Completion (ACTUAL)

October 1, 2002

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (ESTIMATE)

March 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-NEP-0011
  • D9615C00011

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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