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

Takepron Specified Drug-use Survey "Gastroesophageal Reflux Disease With Dyspepsia Symptoms"

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

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease With Dyspepsia Symptoms
• Intervention / Treatment: Drug: Lansoprazole

Detailed 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 Type: Observational
• Enrollment (Actual): 14965

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Gastroesophageal reflux disease with dyspepsia symptoms

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Lansoprazole; 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.

Drug: Lansoprazole; • Reflux esophagitis The usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks. 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 Non-erosive gastroesophageal reflux disease The usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.; Other Names: Takepron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Symptom Improvement Rate	Subjective symptoms were evaluated as "Disappeared," "Improved," "No change," "Worsened," or "Unclear." These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of "Disappeared" + "Improved") was calculated for each symptom. The percentage of participants with Improvement by symptom was reported.	Start of treatment and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events (Adverse Drug Reactions)	Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported.	4 Weeks

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Dyspepsia; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 467-531; JapicCTI-132310 (Registry Identifier: Japic CTI); JapicCTI-R140645 (Registry Identifier: JapicCTI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No