NCT00625495

Brief Summary

The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

February 20, 2008

Last Update Submit

January 21, 2011

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux diseaseNexiumEsomeprazoleAdministration methods.

Outcome Measures

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.

    Every 10 days

Secondary Outcomes (3)

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

    Post Day 10

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

    Post Day 10

  • Safety assessment via adverse event recording

    At each visit

Study Arms (2)

1

EXPERIMENTAL

IV Nexium

Drug: Esomeprazole

2

EXPERIMENTAL

Oral Nexium

Drug: Esomeprazole

Interventions

EsomeprazoleDRUG

40mg Intravenous infusion over 3 minutes

Also known as: Nexium
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Body Mass Index within the limits specified in the protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic 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

February 20, 2008

First Posted

February 28, 2008

Study Start

September 1, 2002

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

January 24, 2011

Record last verified: 2011-01