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

NCT02708355 | Completed Phase 4 Results

• 2 other identifiers: B5141005ACID CONTROL EXPLORATORY STUDY
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Heartburn

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Esomeprazole 20 mg once daily

EXPERIMENTAL

Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening

Drug: Esomeprazole 20 mg; Drug: Placebo

Esomeprazole 20 mg twice daily

EXPERIMENTAL

Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening

Drug: Esomeprazole 20 mg

Placebo

PLACEBO COMPARATOR

Placebo administered orally in the morning and placebo administered orally in the evening

Drug: Placebo

Interventions

Esomeprazole 20 mg DRUG

Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)

Also known as: Nexium

Esomeprazole 20 mg once daily; Esomeprazole 20 mg twice daily

Placebo DRUG

Placebo capsules

Esomeprazole 20 mg once daily; Placebo

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73102, United States

Location

St. Anthony Hospital - Conference Rooms

Oklahoma City, Oklahoma, 73102, United States

Location

Related Publications (1)

• 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.

  PMID: 30255418 DERIVED

Related Links

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

MeSH Terms

Conditions

Heartburn

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: March 15, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2017
• Results First Posted: April 19, 2017

Record last verified: 2017-03

Locations

US (2)