NCT01499368 is a Phase 3 clinical trial of Lafutidine in Erosive Esophagitis, sponsored by Boryung Pharmaceutical Co., Ltd.

Who is sponsoring NCT01499368?

NCT01499368 is sponsored by Boryung Pharmaceutical Co., Ltd.

What drugs are being tested in NCT01499368?

Interventions in NCT01499368: Lafutidine, Famotidine, Omeprazole.

What condition does NCT01499368 study?

NCT01499368 studies Erosive Esophagitis.

Is NCT01499368 still recruiting?

NCT01499368 is currently completed. Last updated 6 January 2025.

Are results published for NCT01499368?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-06 · How we verify

NCT01499368

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 6 January 2025

What this trial tests

Phase 3 trial testing Lafutidine in Erosive Esophagitis in 495 participants. Completed in 1 November 2012.

Timeline

1 November 2011

Primary endpoint
1 November 2012

1 November 2012

Quick facts

Lead sponsor	Boryung Pharmaceutical Co., Ltd
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	495
Start date	1 November 2011
Primary completion	1 November 2012
Estimated completion	1 November 2012

Drugs / interventions tested

Lafutidine (LAFUTIDINE) — full drug profile →
Famotidine (famotidine) — full drug profile →
Omeprazole (omeprazole) — full drug profile →

Conditions studied

Erosive Esophagitis — all drugs for Erosive Esophagitis →

Sponsor

Boryung Pharmaceutical Co., Ltd — full company profile →

Who can join

Adults 20 to 75, any sex, with Erosive Esophagitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

To evaluate the healing rate and safety of Lafutidine in erosive esophagitis

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lafutidine

Trials testing the same drug.

NCT02759224 — A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet · Phase 1 · completed

Other recruiting trials for Erosive Esophagitis

Currently open trials in the same condition.

NCT02615184 — A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in C · Phase 2 · active not recruiting
NCT05267613 — Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis. · Phase 3 · recruiting
NCT04255693 — Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence · NA · recruiting

Other Boryung Pharmaceutical Co., Ltd trials

Trials by the same sponsor.

NCT07421414 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
NCT07421401 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
NCT07421388 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
NCT07421375 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
NCT07373613 — A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01499368 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boryung Pharmaceutical Co., Ltd
Last refreshed: 6 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01499368.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing