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

Takeda

Status: Completed

Conditions: Gastroesophageal Reflux Disease With Dyspepsia Symptoms

Treatments: Drug: Lansoprazole

Study type: Observational

Funder types: Industry

Identifiers

NCT01990339

JapicCTI-R140645 (Registry Identifier)

467-531

JapicCTI-132310 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 14,965 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

14,965 participants in 1 patient group

Lansoprazole

Description:

Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy 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. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.

Treatment:

Drug: Lansoprazole