Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer
ConditionGastric Ulcer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.
About this trial
A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants with Gastric Ulcer
Eligibility criteria
Qualifiers
At least one gastric ulcer is present, and the largest gastric ulcer measures ≥ 3 mm and ≤ 30 mm in diameter
The Sakita-Miwa classification of the largest gastric ulcer is A1 or A2.
Disqualifiers
Participants with a history of Zollinger-Ellison syndrome or conditions associated with gastric hypersecretion.
Participants who, within 30 days prior to the screening visit (Visit 1), have undergone or are scheduled to undergo major surgery that may affect gastric acid secretion.
Participants with a history of malignancy within 5 years prior to the screening visit (Visit 1); gastrointestinal malignancies are excluded regardless of the time elapsed.
Participants who, at the screening visit (Visit 1), have gastrointestinal active bleeding , esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (> 3 cm), esophageal dysplasia, duodenal ulcer, refractory ulcer, perforated ulcer, or surgery-induced ulcer
Trial design
Treatments tested in this trial
- DWP14012 40mg (Fexuprazan)
- Lansoprazole 30mg
Treatment groups
384 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov