CompletedPhase 3

Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis

South Korea351 participantsStarted 2019-06-18

Plain-language summary

This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

Who can participate

Age range20 Years – 75 Years

SexALL

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Inclusion criteria

✓. Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
✓. Healed erosive esophagitis within 7 days prior to Randomization
✓. No heartburn and regurgitation within 7 days prior to Randomization

Exclusion criteria

✕. Unable to undergo upper GI endoscopy
✕. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
✕. Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
✕. History of acid-suppressive, esophageal or gastric surgeries

What they're measuring

Endoscopic remission rate of EE at 24-week

Timeframe: 24-week

Trial details

NCT IDNCT04022096

SponsorHK inno.N Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-23

View on ClinicalTrials.gov More Healed Erosive Esophagitis trials