Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
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.
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 sufficient healing effects. Haruma thinks that the first choice should be PPI in principle which has the best therapeutic effect as the medical guideline if a patient has a strong reflux symptom such as heartburn or is diagnosed with severe reflux oesophagitis (Grade C or D according to the Los Angels Classification) as a result of the upper gastrointestinal endoscopic test. Later, after healing is confirmed at 8 weeks of treatment or after the subjective symptoms have been improved, the dose of PPI should be reduced to half to transfer to maintenance therapy. On the other hand, if a patient has mild subjective symptoms or develops mild reflux oesophagitis (Grade A or B according to the Los Angels Classification) as a result of the upper gastrointestinal endoscopic test, only about 10% of such patients aggravate in the long-run and some patients heal in the natural course. Therefore, considering that Japanese gastric-acid secretion is lower than Westerners, they recommend that antacids such as H2 receptor antagonists or sodium alginates is used to treat symptoms as they appear along with the improvement in the lifestyle. As mentioned above, lafutidine that strongly suppresses acid secretion during the daytime from the initial phase of treatment is expected to demonstrate sufficient effect in treatment of mild reflux oesophagitis similar to the conventional H2 receptor antagonists.
Based on above, the clinical trial is planned with the objective to confirmedly demonstrate the efficacy of lafutidine in mild reflux oesophagitis.
Comparisons: The endoscopic healing rate of lafutidine in the patients with mild reflux oesophagitis is compared to the rate of placebo and it is also compared to the rate of famotidine.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Gastroesophageal Reflux
Intervention
Lafutidine, Famotidine, Placebo
Location
Tohoku University Hospital
1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi
Japan
980-8574
Status
Completed
Source
Taiho Pharmaceutical Co., Ltd.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00229424
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bile Reflux
Retrograde bile flow. Reflux of bile can be from the duodenum to the stomach (DUODENOGASTRIC REFLUX); to the esophagus (GASTROESOPHAGEAL REFLUX); or to the PANCREAS.
Eosinophilic Esophagitis
Chronic ESOPHAGITIS characterized by esophageal mucosal EOSINOPHILIA. It is diagnosed when an increase in EOSINOPHILS are present over the entire esophagus. The reflux symptoms fail to respond to PROTON PUMP INHIBITORS treatment, unlike in GASTROESOPHAGEAL REFLUX DISEASE. The symptoms are associated with IgE-mediated hypersensitivity to food or inhalant allergens.
Regurgitation, Gastric
GASTROESOPHAGEAL REFLUX wherein the retrograde flow passes through the UPPER ESOPHAGEAL SPHINCTER
Esophageal Ph Monitoring
Analysis of the HYDROGEN ION CONCENTRATION in the lumen of the ESOPHAGUS. It is used to record the pattern, frequency, and duration of GASTROESOPHAGEAL REFLUX.
Esophageal Motility Disorders
Disorders affecting the motor function of the UPPER ESOPHAGEAL SPHINCTER; LOWER ESOPHAGEAL SPHINCTER; the ESOPHAGUS body, or a combination of these parts. The failure of the sphincters to maintain a tonic pressure may result in gastric reflux of food and acid into the esophagus (GASTROESOPHAGEAL REFLUX). Other disorders include hypermotility (spastic disorders) and markedly increased amplitude in contraction (nutcracker esophagus).
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