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

GERD Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635414
• Other study ID #: SH-NEP-0011
• Secondary ID: D9615C00011
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2008
• Last updated: January 24, 2011
• Start date: August 2002
• Est. completion date: October 2002

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• Esomeprazole
40mg oral
• Esomeprazole
15 minute intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.		MAO will be assessed after 10 days of treatment (Day 11 or Day 20)
Secondary	Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)		BAO will be assessed after 10 days of treatment
Secondary	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.		Assessments at Day 2 and after Day 10 (Day 11 or Day 20)
Secondary	To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.		Safety assessments throughout the study