Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04066530
Other study ID # AD-203P3
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 23, 2019
Est. completion date February 26, 2020

Study information

Verified date December 2020
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, active-controlled , randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of AD-203 to demonstrate the non-inferiority of AD-203 compared with Mucosta tab. in patients with acute or chronic gastritis


Recruitment information / eligibility

Status Completed
Enrollment 475
Est. completion date February 26, 2020
Est. primary completion date February 26, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - Age is over 20 years old, under 75 years old, men or women - Patients diagnosed with acute or chronic gastritis by gastroscopy Exclusion Criteria: - Patients who is impossible to receive gastroscopy - Patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AD-203
AD-203 administered two times daily for two weeks
Mucosta tab.
Mucosta tab. administered three times daily for two weeks

Locations

Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary A percentage of subjects showed improvement of stomach erosions by the endoscopy. Evaluate the improvement rate of "Very much improved' and "Much improved" of subjects with stomach erosions.
The definition of "Very Much Improved" is the subjects showed score changed from 4 to 1 or from 3 to 1. And, "Much improved" means the subject showed score changed from 4 to 2 or from 2 to 1.
2 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05048069 - Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.
Completed NCT01817556 - A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab. Phase 4
Recruiting NCT01813812 - A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034 Phase 3
Completed NCT00996788 - Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis Phase 3
Completed NCT04341454 - Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis Phase 3
Enrolling by invitation NCT05021029 - A Study of Pre-Malignant Gastric Conditions
Completed NCT05073614 - Evaluation of Immunohistochemical Expression of Heparanase in Helicobacter Pylori-Associated Chronic Gastritis N/A
Completed NCT04697186 - Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy Phase 4
Recruiting NCT00455806 - Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection Phase 3
Recruiting NCT05666531 - Research on Innovative Diagnosis and Treatment System of Syndrome Differentiation of Zang-fu Viscera and Effectiveness Evaluation Based on Inter-Arm Blood Pressure Measured Simultaneously
Completed NCT03847753 - Exploring the Comorbidity Between Mental Disorders and General Medical Conditions
Completed NCT04189705 - A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis Phase 3
Completed NCT05014334 - Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication Phase 4
Completed NCT02356679 - Efficacy and Safety of Eupasidin-s Tab.(EUPASIDIN-S) in Gastritis Patients Phase 4
Completed NCT02219529 - Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases Phase 3
Completed NCT03609892 - Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy Phase 4
Unknown status NCT02282670 - A Study to Evaluate the Efficacy and Safety of DA-5204 Phase 3
Completed NCT01119768 - Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients Phase 4
Completed NCT02658864 - Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets Phase 1