Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis.

Furthermore, the followings are compared:

The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Collaborator: UCB Pharma
• Treatments: Famotidine; Lafutidine

Criteria

Inclusion Criteria:

• Age 20 and over (at the time of consent given)

• Gender and inpatient or outpatient: Irrelevant

• Patients diagnosed with Grade A or Grade B mild reflux oesophagitis (according to the Los Angels classification) through endoscopic test

• Patients who complained about "heartburn symptom" within one week prior to the enrollment

Exclusion Criteria:

• Patients whose "heartburn symptom" has been disappeared (not been observed at all) during the observation period (Check before official enrollment)

• Patients in ill compliance with dosing the investigational product for the observation period (Not more than 75%, check from the patient dairy before official enrollment)

• Patients the investigator/sub-investigator assessed difficult to complete the patient diary during the treatment period because the patient diary for the observation period has too many deficiencies. (Check before official enrollment)

• Patients with complication of gastric/duodenal ulcer (scarring acceptable)

• Patients with complication of Barrett lining over the site exceeding 3 cm of esophageal distal portion

• Patients who have received the normal dose of H2 receptor antagonist or proton pump inhibitor (PPI) for 8 weeks in vain

• Patients whose Helicobacter pylori was successfully eradicated within 24 weeks

• Patients with medical history of upper gastrointestinal tract excision

• Patients with complication of angina pectoris

• Patients who have received treatment of any other investigational product within 12 weeks

• Patients who showed any of the following values at the laboratory tests before official enrollment: Hemoglobin: < 9.5 g/dL, WBC: < 3,000/mm^3, Thrombocytes: < 75,000/mm^3, AST and ALT : ≥ 100 IU/L, Creatinine: ≥ 1.5 mg/dL These should be assessed using the current test values from the blood drawn within 4 weeks prior to official enrollment.

• Patients with complication of serious cardiac disorder (Grade 3 or above under PAB/SD Notification No. 80) For example, patients with triplet or more ventricular premature contractions (multi-sources) or using a pacemaker

• Patients with medical history of serious hypersensitivity to drugs (Grade 3 or above under PAB/SD Notification No. 80)

• Patients who receive treatment of cancer

• Women of confirmed or potential pregnancy, those who wish to become pregnant, and breast feeding women

• Patients having any other condition that, in the opinion of the investigator/sub-investigator disqualifies them for the trial