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

• Drug: Esomeprazole 20 mg
  Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)
  Other Name: Nexium
• Drug: Placebo
  Placebo capsules

• Experimental: Esomeprazole 20 mg once daily
  Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening
  Interventions:

  • Drug: Esomeprazole 20 mg
  • Drug: Placebo
• Experimental: Esomeprazole 20 mg twice daily
  Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening
  Intervention: Drug: Esomeprazole 20 mg
• Placebo Comparator: Placebo
  Placebo administered orally in the morning and placebo administered orally in the evening
  Intervention: Drug: Placebo

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).