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

• ClinicalTrials.gov Identifier: NCT02708355
• Recruitment Status: Completed
• First Posted: March 15, 2016
• Results First Posted: April 19, 2017
• Last Update Posted: April 19, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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.

Condition or disease	Intervention/treatment	Phase
Heartburn	Drug: Esomeprazole 20 mg; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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 Start Date: January 2016
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Esomeprazole 20 mg once daily; Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening	Drug: Esomeprazole 20 mg; Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate); Other Name: Nexium; Drug: Placebo; Placebo capsules
Experimental: Esomeprazole 20 mg twice daily; Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening	Drug: Esomeprazole 20 mg; Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate); Other Name: Nexium
Placebo Comparator: Placebo; Placebo administered orally in the morning and placebo administered orally in the evening	Drug: Placebo; Placebo capsules

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn [ Time Frame: 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.
2. Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, Oklahoma

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States, 73102

St. Anthony Hospital - Conference Rooms

Oklahoma City, Oklahoma, United States, 73102

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02708355
• Other Study ID Numbers: B5141005; ACID CONTROL EXPLORATORY STUDY ( Other Identifier: Alias Study Number )
• First Posted: March 15, 2016
• Results First Posted: April 19, 2017
• Last Update Posted: April 19, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Heartburn; Signs and Symptoms, Digestive; Esomeprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action