N/A
N=185
Genotype-supported Versus Conventional Proton Pump Inhibitor Dosing
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT02930824 ↗Enrolled (actual)
185
Serious AEs
—
Results posted
Jun 2021
Primary outcome: Primary: Reflux Disease Questionnaire (RDQ) — -0.387; -0.296 score on a scale — p=0.78
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CYP2C19 genotyping (Genetic)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reflux Disease Questionnaire (RDQ) |
-0.387; -0.296 | 0.78 |
| PRIMARY Pediatric Sinonasal Symptom Survey (SN-5) |
1.8; 2.6 | 0.031 sig |
| PRIMARY Safety Questionnaire (SafetyQ) |
20; 44 | 0.07 |
| PRIMARY Gastroesophageal Reflux Disease (GERD) Assessment of Symptoms in Pediatrics Questionnaire (Gasp-Q) |
-24.0; -26.0 | 0.97 |
| PRIMARY Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module |
8.2; 5.4 | 0.83 |
Summary
Investigators will conduct a comparative effectiveness study of genotype-supported vs. conventional PPI dosing. Adults and children presenting with Gastroesophageal Reflux Disease (GERD) or dyspepsia symptoms and either 1) being initiated on proton pump inhibitor (PPI) therapy or 2) with continued symptoms on current PPI therapy will be recruited from gastroenterology clinics and randomized to a genotype-supported versus conventional PPI therapy management strategy.
Eligibility Criteria
Pediatric:
Inclusion Criteria
- 5-17 years of age
- diagnosed with GERD or any other stomach acid mediated condition for which a PPI treatment is provided
- currently under a Proton Pump Inhibitor (PPI) therapy or will start a PPI therapy
- Parents/legal guardians and or child must have access to internet and a valid email address
Exclusion Criteria
- history of extensive esophageal or gastric surgery
- diagnosed with any major chronic illness or conditions that in the opinion of the gastroenterologist that would interfere with participation in the study
- history of Phenylketonuria (PKU) and patients with a history of previous adverse effects from PPI treatment or sensitivity to aspartame (NutraSweet, Equal)
Adult:
Inclusion Criteria
- 18 years of age or older
- Gastroesophageal Reflux Disease symptoms
- Being initiated on PPI therapy OR continues to have symptoms despite PPI therapy
Exclusion Criteria
- Extensive esophageal or gastric surgery
- Any chronic illness that would interfere with the study
Data sourced from ClinicalTrials.gov (NCT02930824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.