Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-04-30

Brief Summary

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The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.

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Detailed Description

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Conditions

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Heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Esomeprazole 20 mg once daily

Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening

Group Type EXPERIMENTAL

Esomeprazole 20 mg

Intervention Type DRUG

Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)

Placebo

Intervention Type DRUG

Placebo capsules

Esomeprazole 20 mg twice daily

Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening

Group Type EXPERIMENTAL

Esomeprazole 20 mg

Intervention Type DRUG

Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)

Placebo

Placebo administered orally in the morning and placebo administered orally in the evening

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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Esomeprazole 20 mg

Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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Inclusion Criteria

* Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
* Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
* When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.

Exclusion Criteria

* A history (past or present) of erosive esophagitis verified by endoscopy.
* The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
* Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No