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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DWP14012 40mg (Fexuprazan)
DrugDWP14012 40mg(Fexuprazan) + placebo of Lansoprazole
Lansoprazole 30mg
DrugLansoprazole 30mg + Placebo of DWP14012 40mg
Treatment groups
384 Participants
are divided into 2 treatment groupsGroup A: Study GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8
Time frame
Week 8Secondary outcomes
1
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4
Time frame
Week 42
Gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy at Week 4 according to H. pylori infection status.
Time frame
Week 43
Cumulative gastric ulcer healing rate confirmed by upper gastrointestinal endoscopy through Week 8 according to H. pylori infection status.
Time frame
Week 84
Changes in NDI scores at Weeks 4 and 8.
Time frame
Week 4 and Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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