Trial · NCT01499368

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

NCT01499368, Phase 3, Completed, Boryung Pharmaceutical Co., Ltd; results first posted 2020-09-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT01499368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01499368

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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 Korean Erosive Esophagitis Patients
NCT number: NCT01499368
Status: Completed
Phases: Phase 3
Enrollment: 495 participants, actual
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Conditions: Erosive Esophagitis
Interventions: Lafutidine, Famotidine, Omeprazole
First posted: 2011-12-26
Last updated: 2025-01-15
Results first posted: 2020-09-16

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Recovery Rates of Reflux Esophagitis	8 weeks	Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
Secondary	The Proportion of Days Without 'Cardinal Symptom'	4 or 8 week	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
Secondary	The Proportion of Daytimes Without 'Cardinal Symptom'	4 or 8 week	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
Secondary	The Proportion of Nighttimes Without 'Cardinal Symptom'	4 or 8 week	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

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recovery Rates of Reflux Esophagitis	8 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Proportion of Days Without 'Cardinal Symptom'	4 or 8 week	Missing = Lafutidine(5) , Omeprazole(1)	proportion of days	MEAN
SECONDARY	The Proportion of Daytimes Without 'Cardinal Symptom'	4 or 8 week	Missing = Lafutidine(5) , Omeprazole(1)	proportion of days	MEAN
SECONDARY	The Proportion of Nighttimes Without 'Cardinal Symptom'	4 or 8 week	Missing = Lafutidine(5) , Omeprazole(1)	proportion of days	MEAN

Source ClinicalTrials.gov

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Recovery Rates of Reflux Esophagitis	Lafutidine	Recovered	101		Participants
Recovery Rates of Reflux Esophagitis	Famotidine	Recovered	92		Participants
Recovery Rates of Reflux Esophagitis	Omeprazole	Recovered	126		Participants
Recovery Rates of Reflux Esophagitis	Lafutidine	Not recovered	43		Participants
Recovery Rates of Reflux Esophagitis	Famotidine	Not recovered	53		Participants
Recovery Rates of Reflux Esophagitis	Omeprazole	Not recovered	21		Participants
The Proportion of Days Without 'Cardinal Symptom'	Lafutidine	week 4	0.64	Standard Deviation 0.31	proportion of days
The Proportion of Days Without 'Cardinal Symptom'	Famotidine	week 4	0.56	Standard Deviation 0.32	proportion of days
The Proportion of Days Without 'Cardinal Symptom'	Omeprazole	week 4	0.69	Standard Deviation 0.30	proportion of days
The Proportion of Days Without 'Cardinal Symptom'	Lafutidine	week 8	0.77	Standard Deviation 0.27	proportion of days

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lafutidine	165
Overall Study	STARTED	Famotidine	163
Overall Study	STARTED	Omeprazole	167
Overall Study	COMPLETED	Lafutidine	138
Overall Study	COMPLETED	Famotidine	145
Overall Study	COMPLETED	Omeprazole	146
Overall Study	NOT COMPLETED	Lafutidine	27
Overall Study	NOT COMPLETED	Famotidine	18
Overall Study	NOT COMPLETED	Omeprazole	21

Source ClinicalTrials.gov

Adverse events216

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	Lafutidine	2	165	2
other	Abdominal pain	Gastrointestinal disorders	Famotidine	3	162	4
other	Abdominal pain	Gastrointestinal disorders	Omeprazole	1	167	1
other	Dyspepsia	Gastrointestinal disorders	Lafutidine	1	165	1
other	Dyspepsia	Gastrointestinal disorders	Famotidine	1	162	1
other	Dyspepsia	Gastrointestinal disorders	Omeprazole	4	167	4
other	Abdominal distension	Gastrointestinal disorders	Lafutidine	1	165	1
other	Abdominal distension	Gastrointestinal disorders	Famotidine	2	162	2
other	Abdominal distension	Gastrointestinal disorders	Omeprazole	1	167	1
other	Nausea	Gastrointestinal disorders	Lafutidine	2	165	2

1 to 10 of 216Source ClinicalTrials.gov

See all 216 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lafutidine
Total, all-cause mortality	Famotidine
Total, all-cause mortality	Omeprazole
Total, other adverse events	Lafutidine	36	165
Total, other adverse events	Famotidine	30	162
Total, other adverse events	Omeprazole	34	167
Total, serious adverse events	Lafutidine	0	165
Total, serious adverse events	Famotidine	0	162
Total, serious adverse events	Omeprazole	3	167

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01499368

GET https://conductscience.org/api/trials/v1/NCT01499368/results?page=2

API reference For AI assistants