Overview

Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms

Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
Dexlansoprazole
Lansoprazole
Criteria
Inclusion Criteria:

1. Patients with heartburn or acid regurgitation at the start of Takepron administration*
, or patients without heartburn and acid regurgitation, but with endoscopic findings
classified as Los Angeles grade A-D at the start of Takepron therapy.

2. Patients with symptoms of dyspepsia (i.e., postprandial fullness, early satiation,
epigastric pain, epigastric burning, upper abdominal bloating, nausea/vomiting, or
belching) at the start of Takepron administration* *These patients must have answered
"never, " "sometimes/mild," "often/moderate," or "frequent/severe" on a 4-point scale
questionnaire about subjective symptoms.

Exclusion Criteria:

1. Patients who have taken any proton pump inhibitors (including Takepron) within 4 weeks
before the start of Takepron administration

2. Patients taking antidepressants