Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
Information source: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: Lafutidine (Drug); Famotidine (Drug); Placebo (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Taiho Pharmaceutical Co., Ltd. Official(s) and/or principal investigator(s): Tomoyuki Koike, MD, Principal Investigator, Affiliation: Tohoku University Hospital
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.
Clinical Details
Official title: Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Endoscopic healing rate
Secondary outcome: Frequency of heartburn symptom, intensity and improvement effect in other subjective symptoms and dosing frequency of MALFA ® suspension (neutralizer)
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Tohoku University Hospital, 1-1, Seiryo-cho, Aoba-ku, Sendai, Miyagi 980-8574, Japan
Additional Information
Starting date: April 2005
Last updated: July 6, 2011
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