NCT00206024

Brief Summary

This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_4

Geographic Reach
2 countries

27 active sites

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

November 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

First QC Date

September 12, 2005

Last Update Submit

November 18, 2010

Conditions

Heartburn

Outcome Measures

Primary Outcomes (1)

  • Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".

Secondary Outcomes (7)

  • Relief of heartburn during the 4th week of treatment

  • Cumulative daily sustained resolution rate through 4 weeks of treatment

  • Time to first day of the first 7-day period of sustained resolution of heartburn

  • Time to the first day of the first 7-day period of relief of heartburn

  • Percentage of subject-reported heartburn-free days through 4 weeks of treatment

  • +2 more secondary outcomes

Interventions

Esomeprazole magnesium (Nexium)DRUG

Eligibility Criteria

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

You may qualify if:

  • Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
  • A history of heartburn for at least 6 months
  • A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
  • A positive esophageal acid perfusion test
  • At least 3 days of 'moderate' severity heartburn over the previous 7 days
  • No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization

You may not qualify if:

  • A history of gastric or esophageal surgery
  • H. pylori positive
  • A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
  • Currently taking higher than the standard approved proton pump inhibitor doses
  • Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Tucson, Arizona, United States

Location

Research Site

Anaheim, California, United States

Location

Research Site

Orange, California, United States

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Research Site

San Diego, California, United States

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Research Site

Washington D.C., District of Columbia, United States

Location

Research Site

DeLand, Florida, United States

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Research Site

Miami, Florida, United States

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Research Site

New Smyrna Beach, Florida, United States

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Research Site

Tampa, Florida, United States

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Research Site

Zephyrhills, Florida, United States

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Research Site

Atlanta, Georgia, United States

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Research Site

Chicago, Illinois, United States

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Research Site

New Orleans, Louisiana, United States

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Research Site

Annapolis, Maryland, United States

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Research Site

Baltimore, Maryland, United States

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Research Site

Hollywood, Maryland, United States

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Research Site

Attleboro, Massachusetts, United States

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Research Site

Hackensack, New Jersey, United States

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Research Site

Vineland, New Jersey, United States

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Research Site

Rochester, New York, United States

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Research Site

Asheville, North Carolina, United States

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Research Site

Elkin, North Carolina, United States

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Research Site

Guthrie, Oklahoma, United States

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Research Site

Philadelphia, Pennsylvania, United States

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Research Site

Knoxville, Tennessee, United States

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Research Site

Christiansburg, Virginia, United States

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Research Site

Ponce, Puerto Rico

Location

MeSH Terms

Conditions

Heartburn

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nexium Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Study Completion

July 1, 2005

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

US(26)PR(1)