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OpenTrials
Completed

NCT Number: NCT00626262

Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

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Key information

Conditions

Gastroesophageal Reflux Disease 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 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
  • Body Mass Index within the limits specified in the protocol.

Exclusion criteria

  • History of esophageal, duodenal or gastric surgery
  • History of severe liver disease.
  • Any other significant disease or pathology judged to be clinically significant by the investigator.

Treatment and study plan

Esomeprazole

Drug

Oral and Intravenous

Other names: Nexium

Primary outcomes

  1. To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.

    Time frame: Every 10 days

Secondary outcomes

  1. To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.

    Time frame: Post Day 10

  2. To compare maximum acid output when switching between Oral and IV adminstration of Nexium

    Time frame: Post Day 10

  3. Safety assessment via adverse event recording.

    Time frame: At each visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open, Randomised Two Way Crossover Study Comparing the Effects of 20mg of Esomeprazole Administered Orally and Intravenously as a 3 Minute Injection 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
Feb 29, 2008
Registry last updated
Jan 24, 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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