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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.

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date December 21, 2021
Actual Study Start Date  ICMJE June 2, 2020
Actual Primary Completion Date August 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
Improvement rate of gastric mucosal erosion [ Time Frame: at 2 weeks after the IP administration ]
50% decreased on erosive grade
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Cure rate of gastric mucosal erosion [ Time Frame: at 2 weeks after the IP administration ]
    Erosion score of 1 (0 erosions)
  • Cure rate of gastric mucosal edema at 2week by upper gastrointestinal endoscopy [ Time Frame: at 2week ]
    Reduction from 2 to 1 in edema score
  • Improvement rate of gastric mucosal erythema at 2week by upper gastrointestinal endoscopy [ Time Frame: at 2 weeks after the IP administration ]
    Reduction of ≥ 50% in erythema score
  • Improvement rate of gastric mucosal bleeding at 2week by upper gastrointestinal endoscopy [ Time Frame: at 2 weeks after the IP administration ]
    Reduction of ≥ 50% in bleeding score
  • Improvement rate of subjective symptoms [ Time Frame: at 2 weeks after the IP administration ]
    reduction of ≥ 50% in subjective symptom score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Gastritis
  • Chronic Gastritis
Intervention  ICMJE
  • Drug: DWP14012 X mg
    DWP14012 X mg, tablet, orally, once daily for 2 weeks
  • 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
  • Drug: DWP14012 Y mg placebo
    DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: DWP14012 X mg
    • Drug: DWP14012 Y mg placebo
  • 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
    Interventions:
    • Drug: DWP14012 X mg placebo
    • Drug: DWP14012 Y mg
  • 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
    Interventions:
    • Drug: DWP14012 X mg placebo
    • Drug: DWP14012 Y mg placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2020)
327
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 16, 2021
Actual Primary Completion Date August 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04341454
Other Study ID Numbers  ICMJE DW_DWP14012305
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Daewoong Pharmaceutical Co. LTD.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP