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

Heartburn Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02708355
• Other study ID #: B5141005
• Secondary ID: ACID CONTROL EXP
• Status: Recruiting
• Phase: Phase 4
• First received: January 21, 2016
• Last updated: March 9, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Heartburn

Intervention

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

Locations

Country	Name	City	State
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percentage of time with intragastric Power of Hydration (pH) greater than 4 and relief of 24 hour heartburn at Day 14	Boxplots of change in percentage (%) of time with intragastric Power of Hydration greater than 4 (pH>4) will be plotted for subjects who obtained relief of 24 hour heartburn at Day 14 and subjects who did not obtain relief. A logistic regression will be performed with relief of 24 hour heartburn (yes/no) at Day 14 as the dependent variable and change in % of intragastric pH>4 as the independent variable, controlling for age, sex and BMI.	Day 14	No

External Links

•   To obtain contact information for a study center near you, click here.