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

Phase 4

Completed

• Conditions: Heartburn
• Interventions: Drug: Esomeprazole 20 mg; Drug: Placebo

• Registration Number: NCT02708355
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-03
• Results First Submitted: 2017-03-08
• Results First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-08
• Results First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole 20 mg once daily	Esomeprazole 20 mg	Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening
Esomeprazole 20 mg twice daily	Esomeprazole 20 mg	Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening
Placebo	Placebo	Placebo administered orally in the morning and placebo administered orally in the evening
Esomeprazole 20 mg once daily	Placebo	Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening

Primary Outcome Measures

Name	Time	Method
Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4	Baseline, Day 14	Percentage of time was calculated over the 24 hour period during which intra gastric pH \>4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days \[Days 8 - 14\] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days \[Day 8 - 14\] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH \>4 was observed, was reported.
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn	Day 8 up to Day 14	Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days \[Days 8 - 14\] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days \[Day 8 - 14\] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported.

Trial Locations

Locations (2)

Oklahoma Foundation for Digestive Research; 🇺🇸 Oklahoma City, Oklahoma, United States

St. Anthony Hospital - Conference Rooms; 🇺🇸 Oklahoma City, Oklahoma, United States