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

NCT00635414 | Completed Phase 4

• 2 other identifiers: SH-NEP-0011D9615C00011
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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)

Conditions

GERD

Keywords

Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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)

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

  Safety assessments throughout the study

Study Arms (2)

1

EXPERIMENTAL

40mg administered orally

Drug: Esomeprazole

2

EXPERIMENTAL

15 minute intravenous infusion

Drug: Esomeprazole

Interventions

Esomeprazole DRUG

40mg oral

Also known as: Nexium

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: August 1, 2002
• Primary Completion: October 1, 2002
• Study Completion: October 1, 2002
• Last Updated: January 25, 2011

Record last verified: 2011-01