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OpenTrials
Completed

NCT Number: NCT00635414

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

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)

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

40mg oral

Other names: Nexium

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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)

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

    Time frame: Safety assessments throughout the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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).

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Mar 13, 2008
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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