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

Primary Purpose

GERD

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Esomeprazole

About this trial

This is an interventional treatment trial for GERD focused on measuring Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

40mg administered orally

15 minute intravenous infusion

Outcomes

Primary Outcome Measures

The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.

Secondary Outcome Measures

Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)

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.

To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.

Full Information

NCT ID

NCT00635414

First Posted

March 6, 2008

Last Updated

January 24, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00635414

Brief Title

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

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).

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

October 2002 (Actual)

Study Completion Date

October 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GERD

Keywords

Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

40mg administered orally

Arm Title

Arm Type

Experimental

Arm Description

15 minute intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

40mg oral

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

15 minute intravenous infusion

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

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)

Title

To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.

Time Frame

Safety assessments throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paula Fernstrom

Organizational Affiliation

Nexium Global Product Director, AstraZeneca

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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