Randomized parallel controlled trial of "on demand" therapy versus continuous therapy of omepral 20mg in effectiveness and safety for the patients {Los Angeles classification grade M (LA M) or more)} diagnosed as the gastroesophageal reflux disease.

UMIN ID: UMIN000001937

Registered date:02/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Gastroesophageal reflux disease (LA gradeM or more)
• Date of first enrollment: 2009/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

"on demand" therapy of omepral 20mg for 24 weeks
continuous therapy of omepral 20mg for 24 weeks

Outcome(s)

• Primary Outcome: Amount of change of GOS score between before and after treatment Amount of change of QULRAS-J score between before and after treatment
• Secondary Outcome: Examination according to symptoms Evaluation of safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who suffer from cancer. 2) Patients who suffer from serious liver disease, kidney disease, heart disease, or Haematological disorder 3) Patients who had the past of irritability for omeprazole 4) Pregnant women and patienst while suckling, and patients who have been hoping for pregnancy for the trial period. 5) Patients who participated in other clinical trials which are thought to influence to the result of this trial within one month before the start of the trial. 6) Patients who refuse endoscopic examination. 7) Patients who suffer from gastric ulcers and/or duodenal ulcers 8) Patients who are judged inappropriate for the clinical trial by doctors.

Related Information

• Primary Sponsor: Department of Gastroenterology Juntendo University School of Medicine
• Source(s) of Monetary Support: none