Comparison of the Efficiency of Two Different PPI Formula in Atypical GERD
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
Patients with atypical gastro-esophageal reflux disease (GERD), include cough, globus, and
non-cardiac chest pain (NCCP) usually require more aggressive or double dose proton pump
inhibitor (PPI) therapy than patients with typical GERD. Dexlansoprazole is a new, dual
delayed release formulation of PPI that increases the mean intragastric pH during a 24-hour
period. The prospective, open-label, randomized study aims to compare the efficacy of two
different PPI formula in treating patients with atypical GERD symptoms.
Patients with atypical GERD symptoms and a total Reflux Symptom Index (RSI) score ≥13 (cough,
globus, and NCCP) will be invited to participate. Personal characteristics including age,
sex, body mass index, and the severity of erosive esophagitis will be recorded. After
enrollment, 120 subjects will randomly assign (at a 1:1 ratio) to receive either oral
lansoprazole, Takepron OD 30 mg, once daily before breakfast or oral dexilansoprazole,
Dexilant 60 mg, once daily before breakfast for 8 weeks. Subjects will record their symptoms
(cough, globus, NCCP, heart burn, and acid regurgitation) at daytime and nighttime everyday
via diary for 8 weeks. The primary endpoint is to compare the cumulated incidence of each
symptom free during 8-week therapy period between the two study groups. The secondary
endpoint will be the withdrawal or drop-out rate due to poor symptoms response or drug
adverse effects.
Data will be analyzed with SPSS Statistical Software for descriptive statistics (percentage,
mean, standard error, and 95% confidence interval) and analytical statistics (chi-square
test, ANOVA, and generalized estimation equation; GEE).