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

Last updated on May 10, 2018

FOR MORE INFORMATION
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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Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Heartburn
  • 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 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2016
April 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
22 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02708355
B5141005
ACID CONTROL EXPLORATORY STUDY ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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