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CompletedNCT00629564Updated Jan 25, 2011

An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg 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)

A Phase 4 interventional study of Esomeprazole and Esomeprazole in GERD, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-25.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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)

02

Conditions studied

  • GERD

Keywords

  • Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    1

    20mg oral

    Drug: Esomeprazole

  • Active comparator
    2

    15 minute intravenous infusion

    Drug: Esomeprazole

Interventions

  • DrugEsomeprazole

    20mg oral

    Also known as: Nexium

  • DrugEsomeprazole

    15 minute intravenous infusion

    Also known as: Nexium

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00629564
Lead sponsor
AstraZeneca
First posted
Mar 6, 2008
Start date
Sep 2002
Primary completion
Oct 2002
Completion
Oct 2002
Last update
Jan 25, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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