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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Heartburn

Treatments: Drug: Esomeprazole 20 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02708355

B5141005

ACID CONTROL EXPLORATORY STUDY (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 3 patient groups, including a placebo group

Esomeprazole 20 mg once daily

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Esomeprazole 20 mg

Esomeprazole 20 mg twice daily

Experimental group

Description:

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

Treatment:

Drug: Esomeprazole 20 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo