Who is sponsoring NCT03418337?

NCT03418337 is sponsored by Taipei Veterans General Hospital, Taiwan.

What condition does NCT03418337 study?

NCT03418337 studies Compare the Response Rate of Atypical GERD After PPI Therapy.

What drugs are being tested in NCT03418337?

Interventions: dexilansoprazole (Dexilant 60 mg), lansoprazole (Takepron OD 30 mg).

What is the status of NCT03418337?

NCT03418337 is currently UNKNOWN.

Last reviewed 2018-01-31 · How we verify

Comparison of the Efficiency of Two Different PPI Formula in Treatment of Atypical GERD Patients, a Randomized Study

NCT03418337 NA UNKNOWN

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).

Details

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	NA
Status	UNKNOWN
Enrolment	120
Start date	2017-08-01
Completion	2018-12

Conditions

Compare the Response Rate of Atypical GERD After PPI Therapy

Interventions

dexilansoprazole (Dexilant 60 mg)
lansoprazole (Takepron OD 30 mg)

Primary outcomes

The response rate of atypical GERD symptom — 8 weeks
evaluate the response rate (symptom free) everyday during the 8-week PPI therapy for cough, globus sensation, NCCP, acid regurgitation, and heartburn respectively

Countries

Taiwan