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

Last updated on November 14, 2019

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Study Location
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73102 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heartburn
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
22-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT02708355
Pfizer
Completed
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment

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Descriptive Information
Brief Title  ICMJE Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Heartburn
Intervention  ICMJE
  • Drug: Esomeprazole 20 mg
    Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)
    Other Name: Nexium
  • Drug: Placebo
    Placebo capsules
Study Arms  ICMJE
  • Experimental: Esomeprazole 20 mg once daily
    Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening
    Interventions:
    • Drug: Esomeprazole 20 mg
    • Drug: Placebo
  • Experimental: Esomeprazole 20 mg twice daily
    Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening
    Intervention: Drug: Esomeprazole 20 mg
  • Placebo Comparator: Placebo
    Placebo administered orally in the morning and placebo administered orally in the evening
    Intervention: Drug: Placebo
Publications *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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2016)
55
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2016)
100
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion DateApril 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 22 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02708355
Other Study ID Numbers  ICMJE B5141005
ACID CONTROL EXPLORATORY STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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