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Study to Demonstrate the Maintenance Effect of Treatment and Confirm the Safety of DWP14012 in Patients With Healed Erosive Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341428
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Brief Summary:
This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.

Condition or disease Intervention/treatment Phase
Healed Erosive Esophagitis Drug: DWP14012 X mg Drug: DWP14012 Xmg placebo Drug: Lansoprazole 15 mg Drug: Lansoprazole 15 mg Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis
Estimated Study Start Date : May 30, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DWP14012 Xmg
Orally, once daily
Drug: DWP14012 X mg
DWP14012 X mg, tablet, orally, once daily for up to 24 weeks

Drug: Lansoprazole 15 mg Placebo
Lansoprazole 15mg Placebo capsule, orally, once daily for up to 24 weeks

Active Comparator: Lansoprazole 15mg
Orally, once daily
Drug: DWP14012 Xmg placebo
DWP14012 Xmg placebo-matching tablet, orally, once daily for up to 24 weeks

Drug: Lansoprazole 15 mg
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks




Primary Outcome Measures :
  1. Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24 [ Time Frame: at 24 week ]

Secondary Outcome Measures :
  1. Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12 [ Time Frame: at 12 week ]

Other Outcome Measures:
  1. GERD-Health related quality life(HRQL) [ Time Frame: at Weeks 4, 12, and 24 ]
    Changes from baseline in the total score of GERD-HRQL at Weeks 4, 12, and 24

  2. Assessment on symptoms [ Time Frame: Weeks 4, 12, and 24 ]
    Proportions of subjects without the major symptoms (heartburn and/or acid regurgitation) at Weeks 4, 12, and 24



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
  2. Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
  3. Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis

Exclusion Criteria:

  1. Subjects who have Barrett's esophagus (> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening
  2. Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
  3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
  4. Subjects who have had a malignant tumor in the last 5 years
  5. Subjects who must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin [100 mg/day] which has been administered for prophylactic purpose before study entry is allowed)
  6. Subjects who cannot stop the existing erosive esophagitis treatment being taken

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341428


Contacts
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Contact: Oh-Young Lee 82-2-2290-8637 leeoy@hanyang.ac.kr

Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04341428    
Other Study ID Numbers: DW_DWP14012303
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action