Trial · NCT01008696

An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis

NCT01008696, Phase 4, Completed, Janssen Korea, Ltd., Korea; results first posted 2013-08-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis. Trials, record NCT01008696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01008696

On this page

Trial

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

Title: An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis
NCT number: NCT01008696
Status: Completed
Phases: Phase 4
Enrollment: 217 participants, actual
Lead sponsor: Janssen Korea, Ltd., Korea
Conditions: Reflux Esophagitis
Interventions: Rabeprazole, Lansoprazole
First posted: 2009-11-06
Last updated: 2013-08-13
Results first posted: 2013-08-13

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Day 57	Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers.
Secondary	Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire	Baseline and Day 57	Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping.
Secondary	Overall Assessment of Study Medication by Investigator	Day 57	Investigator's overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Day 57	The Full analysis set (FAS) included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire	Baseline and Day 57	The FAS included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure	Units on a scale	MEAN
SECONDARY	Overall Assessment of Study Medication by Investigator	Day 57	The FAS included participants who received the study medication at least once and had follow-up data that could be used after the Baseline among the participants meeting the eligibility criteria of this study. LOCF was used. Here, 'N'=participants evaluated for this outcome measure.	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group68

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Rabeprazole	Homozygous Extensive Metabolizer (n=42, 35)	97.37		Percentage of participants
Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Lansoprazole	Homozygous Extensive Metabolizer (n=42, 35)	93.94		Percentage of participants
Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Rabeprazole	Heterozygous Extensive Metabolizer (n=30, 38)	100.00		Percentage of participants
Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Lansoprazole	Heterozygous Extensive Metabolizer (n=30, 38)	100.00		Percentage of participants
Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Rabeprazole	Poor Metabolizer (n=15, 18)	93.33		Percentage of participants
Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19	Lansoprazole	Poor Metabolizer (n=15, 18)	100.00		Percentage of participants
Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire	Rabeprazole	Baseline: Heartburn (n=87, 91)	0.61	Standard Deviation 0.84	Units on a scale
Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire	Lansoprazole	Baseline: Heartburn (n=87, 91)	0.59	Standard Deviation 0.89	Units on a scale
Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire	Rabeprazole	Baseline:Regurgitation (n=87, 91)	0.98	Standard Deviation 0.93	Units on a scale
Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire	Lansoprazole	Baseline:Regurgitation (n=87, 91)	0.93	Standard Deviation 0.96	Units on a scale

1 to 10 of 68Source ClinicalTrials.gov

See all 68 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rabeprazole	108
Overall Study	STARTED	Lansoprazole	109
Overall Study	COMPLETED	Rabeprazole	91
Overall Study	COMPLETED	Lansoprazole	92
Overall Study	NOT COMPLETED	Rabeprazole	17
Overall Study	NOT COMPLETED	Lansoprazole	17

Source ClinicalTrials.gov

Adverse events30

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
other	Abdominal distension	Gastrointestinal disorders	Rabeprazole	19	108
other	Abdominal distension	Gastrointestinal disorders	Lansoprazole	18	109
other	Abdominal pain	Gastrointestinal disorders	Rabeprazole	12	108
other	Abdominal pain	Gastrointestinal disorders	Lansoprazole	17	109
other	Dyspepsia	Gastrointestinal disorders	Rabeprazole	10	108
other	Dyspepsia	Gastrointestinal disorders	Lansoprazole	15	109
other	Abdominal pain upper	Gastrointestinal disorders	Rabeprazole	9	108
other	Abdominal pain upper	Gastrointestinal disorders	Lansoprazole	12	109
other	Dysphagia	Gastrointestinal disorders	Rabeprazole	10	108
other	Dysphagia	Gastrointestinal disorders	Lansoprazole	10	109

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rabeprazole
Total, all-cause mortality	Lansoprazole
Total, other adverse events	Rabeprazole	42	108
Total, other adverse events	Lansoprazole	42	109
Total, serious adverse events	Rabeprazole	2	108
Total, serious adverse events	Lansoprazole	0	109

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 comparisons1

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

Comparison
Rabeprazole vs Lansoprazole: serious adverse events

Source Trial comparisons

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/NCT01008696

GET https://conductscience.org/api/trials/v1/NCT01008696/results?page=2

API reference For AI assistants