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Clinical Trial Summary

To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms


Clinical Trial Description

This is a special drug use surveillance of lansoprazole (Takepron) with a 4-week observational period, designed to evaluate the efficacy in gastroesophageal reflux disease patients with dyspepsia symptoms (planned sample size, 15000).

The dosage regimen is as follows:

- For reflux esophagitis, the usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks. For maintenance treatment of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily.

- For non-erosive gastroesophageal reflux disease, the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01990339
Study type Observational
Source Takeda
Contact
Status Completed
Phase N/A
Start date December 2008
Completion date December 2010