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

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

Detailed Description
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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.

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

Conditions
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Gastroesophageal Reflux Disease With Dyspepsia Symptoms

Intervention / Treatment
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* Drug: Lansoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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: Patients who have taken any proton pump inhibitors (including Takepron) within 4 weeks before the start of Takepron administration Patients taking antidepressants
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lansoprazole<br>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<br>* • 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.<br>* Other names: Takepron;|

What is the study measuring?
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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 |