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CompletedNCT00229424Updated Jul 7, 2011

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

A Phase 3 interventional study of Lafutidine and Famotidine in Gastroesophageal Reflux, sponsored by Taiho Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-07-07.

Sponsored by Taiho Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

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.

Read the 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.

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Conditions studied

  • Gastroesophageal Reflux

Keywords

  • lafutidine
  • reflux oesophagitis
  • Gastroesophageal Reflux
  • famotidine
  • Double Blind
  • Controlled Study
  • H2 receptor antagonist
  • H2-blocker
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In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 325 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Taiho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
325 participants

Study arms

  • Experimental
    1

    Lafutidine group

    Drug: Lafutidine

  • Active comparator
    2

    Famotidine group

    Drug: Famotidine

  • Placebo comparator
    3

    Placebo group

    Other: Placebo

Interventions

  • DrugLafutidine

    Oral administration of lafutidine by 20mg/day along with famotidine placebo

  • DrugFamotidine

    Oral administration of famotidine by 40mg/day along with lafutidine placebo

  • OtherPlacebo

    Oral administration of lafutidine placebo along with famotidine placebo

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What researchers measure

Primary outcomes

  1. Endoscopic healing rate

    Time frame: At the eighth week after treatment

Secondary outcomes

  1. Frequency of heartburn symptom, intensity and improvement effect in other subjective symptoms and dosing frequency of MALFA ® suspension (neutralizer)

    Time frame: Everyday

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Study locations

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

Publications

  • Ohara S, Haruma K, Kinoshita Y, Kusano M. [Efficacy evaluation of lafutidine for mild reflux esophagitis in Japanese patients]. Nihon Shokakibyo Gakkai Zasshi. 2010 Apr;107(4):588-97. Japanese. PubMed 20379093 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00229424
Lead sponsor
Taiho Pharmaceutical Co., Ltd.
Collaborators
UCB Pharma
First posted
Sep 29, 2005
Start date
Apr 2005
Primary completion
Oct 2006
Completion
Jan 2007
Last update
Jul 7, 2011

Study contacts

Tomoyuki Koike, MD
principal investigator · Tohoku University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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