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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635414
First Posted: March 13, 2008
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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)

Condition Intervention Phase
GERD Drug: Esomeprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • 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) ]
  • To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD. [ Time Frame: Safety assessments throughout the study ]

Estimated Enrollment: 60
Study Start Date: August 2002
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40mg administered orally
Drug: Esomeprazole
40mg oral
Other Name: Nexium
Experimental: 2
15 minute intravenous infusion
Drug: Esomeprazole
15 minute intravenous infusion
Other Name: Nexium

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635414


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00635414     History of Changes
Other Study ID Numbers: SH-NEP-0011
D9615C00011
First Submitted: March 6, 2008
First Posted: March 13, 2008
Last Update Posted: January 25, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action