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Gastroesophageal RefluxPhase 3NCT00229424

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

A Phase 3 study testing Lafutidine and Famotidine in people with Gastroesophageal Reflux, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastroesophageal Reflux
What is being tested?
Lafutidine and Famotidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
325 participants
Where
1 siteJapan
Study dates
Apr 2005to Jan 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Tohoku University Hospital

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

Other trials in Japan

About this study

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.

Being tested
Lafutidine, Famotidine, Placebo
Keywords
lafutidine, reflux oesophagitis, Gastroesophageal Reflux, famotidine, Double Blind, Controlled Study, H2 receptor antagonist, H2-blocker
Medical subject headings
Gastroesophageal Reflux, Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LafutidineDrug

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

  • FamotidineDrug

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

  • PlaceboOther

    Oral administration of lafutidine placebo along with famotidine placebo

Study groups in NCT00229424
Study groupRoleWhat they receive
1ExperimentalLafutidine group
Receives: Drug: Lafutidine
2Active comparatorFamotidine group
Receives: Drug: Famotidine
3Placebo comparatorPlacebo group
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endoscopic healing rate

    Measured: At the eighth week after treatment

Secondary outcomes (1)

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

    Measured: Everyday

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionOct 2006
  4. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
325 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00229424
Sponsor's protocol ID
10019350
Other IDs
LAF/GER/3D1/FN/01
Status last verified
Jul 2011
First submitted
28 Sep 2005
Last updated
7 Jul 2011
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lafutidine and Famotidine in people with Gastroesophageal Reflux, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endoscopic healing rate (time frame: At the eighth week after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00229424, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2011.

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