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Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis

ConditionHealed Erosive Esophagitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-75
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients with Healed Erosive Esophagitis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult men and women aged 19 to 75 years at the time of written informed consent

Diagnosed with EE on an upper gastrointestinal endoscopy prior to the initiation of standard therapy

Healing of EE confirmed by upper gastrointestinal endoscopy performed prior to Visit 2 (Randomization), defined as the absence of mucosal breaks according to the LA Grade classification, after completion of standard therapy

Able to understand the information provided and complete the questionnaire

Disqualifiers

Presence of heartburn or acid regurgitation within 7 days prior to Visit 2 (Randomization)

On screening upper gastrointestinal endoscopy, presence of Barrett's esophagus (>3 cm), esophageal varices, esophageal stricture, ulcer-related stricture, active peptic ulcer, acute gastrointestinal bleeding, or malignancy

Patients with inflammatory bowel disease , irritable bowel syndrome, primary esophageal motility disorder, or pancreatitis

History of gastric acid secretion-inhibiting surgery or surgery on the stomach/esophagus (e.g., gastrectomy, endoscopic mucosal resection) or total small bowel resection

Trial design

Design model

Parallel

Treatments tested in this trial

  • DWP14012 20mg

    Drug

    20mg, 1 tablet, Orally, Once a day

  • DWP14012 20 mg placebo

    Drug

    1 tablet, Orally, Once a day

  • DWC202517 15 mg

    Drug

    15mg, 1 capsule, Orally, Once a day

  • DWC202517 15 mg placebo

    Drug

    1 capsule, Orally, Once a day

Treatment groups

420 Participants
are divided into 4 treatment groups
Group A: [Double-blind Treatment Period]Treatment group(DWP14012)Experimental treatment 2 interventions
Group B: [Double-blind Treatment Period]Control group(DWC202517)Active comparator 2 interventions
Group C: [Open-label Extension Period]Maintenance group (DWP14012 20 mg/DWP14012 20 mg group)Experimental treatment 1 intervention
Group D: [Open-label Extension Period]Switch group (DWC202517 15 mg/DWP14012 20 mg group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by an independent central reader, after administration of the IP

Time frame
Week 24

Secondary outcomes

1

Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by the investigator, after administration of the IP

Time frame
Week 24
2

Proportion (%) of subjects who maintain endoscopic remission* up to Week 12, as assessed by an independent central reader and the investigator, after administration of the IP

Time frame
Week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daewoong Pharmaceutical Co. LTD.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: