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

Last updated: July 6, 2011
Sponsor: Taiho Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Heartburn (Pediatric)

Heartburn

Gastroesophageal Reflux Disease (Gerd)

Treatment

N/A

Clinical Study ID

NCT00229424
10019350
LAF/GER/3D1/FN/01
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theLos Angels classification) through endoscopic test

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

Exclusion

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 observationperiod (Not more than 75%, check from the patient dairy before official enrollment)

  • Patients the investigator/sub-investigator assessed difficult to complete the patientdiary during the treatment period because the patient diary for the observation periodhas 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 ofesophageal distal portion

  • Patients who have received the normal dose of H2 receptor antagonist or proton pumpinhibitor (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 12weeks

  • Patients who showed any of the following values at the laboratory tests beforeofficial 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 beassessed using the current test values from the blood drawn within 4 weeks prior toofficial enrollment.

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

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

  • Patients who receive treatment of cancer

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

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

Study Design

Total Participants: 325
Study Start date:
April 01, 2005
Estimated Completion Date:
January 31, 2007

Study 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.

Connect with a study center

  • Tohoku University Hospital

    1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, 980-8574
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.