NIPH Clinical Trials Search

The efficacy of lafutidine on heartburn in patients with mild gastroesophageal reflux disease (GERD)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Mild gastroesophageal reflux disease
Date of first enrollment	2011/07/01
Target sample size	40
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Lafutidine

Outcome(s)

Primary Outcome	Evaluation of GERD symptoms using Frequency Scale for the Symptoms of GERD (FSSG)
Secondary Outcome	Record of symptoms Frequency of heartburn during day and night Evaluation of QOL using Face Scale

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria	1) Patients with Grade N, M, A or B (Los Angeles classification) mild GERD 2) Patients with heartburn symptoms once or more a week 3) More than 20 years old Patients who agree to participate in the study on a written informed consent form
Exclude criteria	1) Patients with hypersensitivity for Lafutidine 2) Patients with serious liver abnormality 3) Patients who took gastric acid inhibitors such as proton pump inhibitor and H2 blocker within 1 week 4) Patients who taking medicine which interfere with the study 5) Patients with depression symptoms 6) Patients considered inappropriate by the study investigator