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Trial record 2 of 19 for:    acute gastritis

Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341454
Recruitment Status : Completed
First Posted : April 10, 2020
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Brief Summary:
The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

Condition or disease Intervention/treatment Phase
Acute Gastritis Chronic Gastritis Drug: DWP14012 X mg Drug: DWP14012 X mg placebo Drug: DWP14012 Y mg Drug: DWP14012 Y mg placebo Phase 3

Detailed Description:
This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Actual Study Start Date : June 2, 2020
Actual Primary Completion Date : August 4, 2021
Actual Study Completion Date : September 16, 2021


Arm Intervention/treatment
Experimental: DWP14012 X mg QD
  • Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo
  • Evening: 1 tablet of DWP14012 Y mg placebo
Drug: DWP14012 X mg
DWP14012 X mg, tablet, orally, once daily for 2 weeks

Drug: DWP14012 Y mg placebo
DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks

Experimental: DWP14012 Y mg BID
  • Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg
  • Evening: 1 tablet of DWP14012 Y mg
Drug: DWP14012 X mg placebo
DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

Drug: DWP14012 Y mg
DWP14012 Y mg, tablet, orally, twice daily for 2 weeks

Placebo Comparator: placebo
  • Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo
  • Evening: 1 tablet of DWP14012 Y mg placebo
Drug: DWP14012 X mg placebo
DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

Drug: DWP14012 Y mg placebo
DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks




Primary Outcome Measures :
  1. Improvement rate of gastric mucosal erosion [ Time Frame: at 2 weeks after the IP administration ]
    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100


Secondary Outcome Measures :
  1. Cure rate of gastric mucosal erosion [ Time Frame: at 2 weeks after the IP administration ]
    Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100

  2. Cure rate of gastric mucosal edema [ Time Frame: at 2 weeks after the IP administration ]
    Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100

  3. Improvement rate of gastric mucosal erythema [ Time Frame: at 2 weeks after the IP administration ]
    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100

  4. Improvement rate of gastric mucosal bleeding [ Time Frame: at 2 weeks after the IP administration ]
    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100

  5. Improvement rate of subjective symptoms [ Time Frame: at 2 weeks after the IP administration ]
    Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100



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:

  • Adults between 19 and 75 years old based on the date of written agreement
  • Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
  • Those who had experienced one or more subjective symptoms of gastritis

Exclusion Criteria:

  • Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
  • Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results

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): NCT04341454


Locations
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Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04341454    
Other Study ID Numbers: DW_DWP14012305
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Gastritis
Gastritis, Atrophic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases