Gastroesophageal reflux disease with dyspepsia symptoms
Conditions
Interventions
investigational material(s)
Generic name etc : Takepron Tablets (lansoprazole)
INN of investigational material :
Therapeutic category code : 232 Agents for peptic ulcer
Dosage and Administration for
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective symptom improvement rate Primary timeframe Start of treatment and Week 4 Subjective symptoms will be evaluated as: "Disappeared," "Improved," "no change," "Worsened," or "Unclear." At Week 4, the rate of improvement (i.e., the frequency of an evaluation of "Disappeared" + "Improved") will be calculated for each symptom. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Secondary timeframe 4 weeks The frequency of drug reactions by type, seriousness and time to onset,. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug. | — |
Outcome results
None listed