Status:
COMPLETED
Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Collaborating Sponsors:
UCB Pharma
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 mi...
Detailed Description
In Japan it is reported that many patients with reflux oesophagitis are relatively mild and do not usually require strong treatment, and even H2 receptor antagonists are considered to demonstrate suff...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00229424
Start Date
April 1 2005
End Date
January 1 2007
Last Update
July 7 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tohoku University Hospital
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan, 980-8574