Comparison of the Efficiency of Two Different PPI Formula in Atypical GERD

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

1. atypical GERD symptoms (cough, globus, or NCCP)

2. with or without typical GERD symptoms (heartburn or acid regurgitation)

3. A total Reflux Symptom Index (RSI) score ≥13

Exclusion Criteria:

1. Patients who currently took pro-kinetic agents, baclofen, antacid, sucralfate, histamin-2 receptor antagonists, PPI, antitussive, non-steroid anti-inflammatory drugs, anxiolytics, or anti-depressants during screening and during study period

2. Patients who have severe cardiac, pulmonary, hepatic, or renal diseases

3. Patients who have uncured underlying malignancy

4. Patients with laryngeal or pharyngeal disorders

5. Patients with a history of gastrointestinal (GI) surgery, symptoms of GI tract obstruction

6. Patients with a contraindication for PPI use