Back to resultsPilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
Primary Purpose
Heartburn
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole 20 mg
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Heartburn
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).
Sites / Locations
- Oklahoma Foundation for Digestive Research
- St. Anthony Hospital - Conference Rooms
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Esomeprazole 20 mg once daily
Esomeprazole 20 mg twice daily
Placebo
Arm Description
Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening
Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening
Placebo administered orally in the morning and placebo administered orally in the evening
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02708355
Brief Title
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole 20 mg once daily
Arm Type
Experimental
Arm Description
Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening
Arm Title
Esomeprazole 20 mg twice daily
Arm Type
Experimental
Arm Description
Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally in the morning and placebo administered orally in the evening
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20 mg
Other Intervention Name(s)
Nexium
Intervention Description
Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules
Primary Outcome Measure Information:
Title
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn
Description
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.
Time Frame
Day 8 up to Day 14
Title
Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4
Description
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.
Time Frame
Baseline, Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
St. Anthony Hospital - Conference Rooms
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30255418
Citation
Miner PB, Johnson DA, Katz PO, Li J, Gatoulis SC, Pollack C. Pilot, Randomized, Blinded, Placebo-Controlled Trial Investigating the Correlation Between Acid Control and Heartburn Relief with 14 Days of Esomeprazole Treatment. Adv Ther. 2018 Nov;35(11):2024-2040. doi: 10.1007/s12325-018-0792-z. Epub 2018 Sep 25.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5141005&StudyName=A%20Pilot%20Phase%20Iv%2C%20Multicenter%2C%20Randomized%2C%20Double%20Blind%2C%20Placebo-controlled%2C%20Parallel%20Study%20To%20Investigate%20The%20Correlation%20Between%20Ph%20Control%20And%20Heartburn%20Symptoms%20After%2014%20Days%20Of%20Proton%20Pump%20Inhibitor%20Treatment%20In%20Subjects%20With%20Frequent%20Heartburn
Description
To obtain contact information for a study center near you, click here.
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5141005&StudyName=A+Pilot+Phase+Iv%2C+Multicenter%2C+Randomized%2C+Double+Blind%2C+Placebo-controlled%2C+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
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
We'll reach out to this number within 24 hrs