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

Study Overview
=================
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.

Official Title
-----------------
A Pilot Phase IV, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Study To Investigate The Correlation Between Ph Control And Heartburn Symptoms After 14 Days Of Proton Pump Inhibitor Treatment In Subjects With Frequent Heartburn

Conditions
-----------------
Heartburn

Intervention / Treatment
-----------------
* Drug: Esomeprazole 20 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole 20 mg once daily<br>Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening | Drug: Esomeprazole 20 mg<br>* Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)<br>* Other names: Nexium;Drug: Placebo<br>* Placebo capsules<br>|
| Experimental: Esomeprazole 20 mg twice daily<br>Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening | Drug: Esomeprazole 20 mg<br>* Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)<br>* Other names: Nexium;|
| Placebo Comparator: Placebo<br>Placebo administered orally in the morning and placebo administered orally in the evening | Drug: Placebo<br>* Placebo capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn | 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. | Day 8 up to Day 14 | 
| Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4 | 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. | Baseline, Day 14 |