EGEND study (Lansoprazole effectiveness on GERD patients with dyspepsia symptoms)
- Conditions
- Gastroesophageal reflux disease with dyspepsia symptoms
- Registration Number
- JPRN-jRCT1080222261
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15000
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.
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 & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective symptom improvement rate<br>Primary timeframe Start of treatment and Week 4<br>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 Outcome Measures
Name Time Method Frequency of adverse drug reactions <br>Secondary timeframe 4 weeks<br>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.