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

July 6, 2011 updated by: Taiho Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment

325

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Lafutidine group
Drug: Lafutidine
Oral administration of lafutidine by 20mg/day along with famotidine placebo
ACTIVE_COMPARATOR: 2
Famotidine group
Drug: Famotidine
Oral administration of famotidine by 40mg/day along with lafutidine placebo
PLACEBO_COMPARATOR: 3
Placebo group
Other: Placebo
Oral administration of lafutidine placebo along with famotidine placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopic healing rate
Time Frame: At the eighth week after treatment
At the eighth week after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of heartburn symptom, intensity and improvement effect in other subjective symptoms and dosing frequency of MALFA ® suspension (neutralizer)
Time Frame: Everyday
Everyday

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: Tomoyuki Koike, MD, Tohoku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

September 28, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (ESTIMATE)

September 29, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

July 7, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10019350
  • LAF/GER/3D1/FN/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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