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

NCT00229424 | Completed Phase 3

• 2 other identifiers: 10019350LAF/GER/3D1/FN/01
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux

Keywords

lafutidine; reflux oesophagitis; Gastroesophageal Reflux; famotidine; Double Blind; Controlled Study; H2 receptor antagonist; H2-blocker

Outcome Measures

Primary Outcomes (1)

• Endoscopic healing rate

  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)

  Everyday

Study Arms (3)

1

EXPERIMENTAL

Lafutidine group

Drug: Lafutidine

2

ACTIVE COMPARATOR

Famotidine group

Drug: Famotidine

3

PLACEBO COMPARATOR

Placebo group

Other: Placebo

Interventions

Lafutidine DRUG

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

1

Famotidine DRUG

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

2

Placebo OTHER

Oral administration of lafutidine placebo along with famotidine placebo

3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead
• UCB Pharma: collaborator

Study Sites (1)

Tohoku University Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 20379093 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophagitis, Peptic

Interventions

lafutidine; Famotidine

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tomoyuki Koike, MD

  Tohoku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 28, 2005
• First Posted: September 29, 2005
• Study Start: April 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: January 1, 2007
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

JP (1)