Erosive EsophagitisPhase 3NCT01499368
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
A Phase 3 study testing Lafutidine, Famotidine and Omeprazole in people with Erosive Esophagitis, run by Boryung Pharmaceutical Co., Ltd.
Trial summary
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- Lafutidine, Famotidine and Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification
Who cannot join
- Gastric or duodenal ulcers (excluding ulcer scars)
- Concurrent presence of Barrett's esophagus
- A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
- Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
About this study
Official title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Koran Erosive Esophagitis Patients
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
- Conditions
- Erosive Esophagitis
- Being tested
- Lafutidine, Famotidine, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LafutidineDrug
Lafutidine 20mg/day
FamotidineDrug
Famotidine 40mg/day
OmeprazoleDrug
Omeprazole 20mg/day
| Study group | Role | What they receive |
|---|---|---|
| Lafutidine | Experimental | Lafutidine 20mg/day Receives: Drug: Lafutidine |
| Famotidine | Active comparator | Famotidine 40mg/day Receives: Drug: Famotidine |
| Omeprazole | Other | Omeprazole 20mg/day Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Rates of Reflux Esophagitis
Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
Measured: 8 weeks
Secondary outcomes (3)
The Proportion of Days Without 'Cardinal Symptom'
The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain
Measured: 4 or 8 week
The Proportion of Daytimes Without 'Cardinal Symptom'
The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain
Measured: 4 or 8 week
The Proportion of Nighttimes Without 'Cardinal Symptom'
The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain
Measured: 4 or 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Woo Lee, Study chair, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499368
- Sponsor's protocol ID
- LAF-BR-CT-302
- Status last verified
- Jan 2025
- First submitted
- 21 Dec 2011
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Koran Erosive Esophagitis Patients
- ClinicalTrials.gov ID
- NCT01499368
- Acronym / sponsor ID
- LAF-BR-CT-302
- Conditions
- Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lafutidine | Experimental | Drug: LafutidineLafutidine 20mg/day |
| Famotidine | Active comparator | Drug: FamotidineFamotidine 40mg/day |
| Omeprazole | Other | Drug: OmeprazoleOmeprazole 20mg/day |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification
Key exclusion criteria (4 listed)
- Gastric or duodenal ulcers (excluding ulcer scars)
- Concurrent presence of Barrett's esophagus
- A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
- Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LafutidineLafutidine 20mg/day | Drug | Lafutidine |
| FamotidineFamotidine 40mg/day | Drug | Famotidine |
| OmeprazoleOmeprazole 20mg/day | Drug | Omeprazole |
Primary outcome
Recovery Rates of Reflux Esophagitis
Time frame: 8 weeks
Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
3 secondary outcomes
The Proportion of Days Without 'Cardinal Symptom'
Time frame: 4 or 8 week
The Proportion of Daytimes Without 'Cardinal Symptom'
Time frame: 4 or 8 week
The Proportion of Nighttimes Without 'Cardinal Symptom'
Time frame: 4 or 8 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Woo Lee study chair
Korea University Ansan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lafutidine, Famotidine and Omeprazole in people with Erosive Esophagitis, run by Boryung Pharmaceutical Co., Ltd.
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 1 inclusion and 4 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recovery Rates of Reflux Esophagitis (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2025.