A Study to Evaluate the Safety and Efficacy of DA9601 for Acute and Chronic Gastritis and to Determine the Optimal Clinical Dosage and Administration

Dong-A ST

Status and phase: Completed; Phase 2

Conditions: Chronic Gastritis; Acute Gastritis

Treatments: Drug: Stillen® Tab Placebo; Drug: Stillen® Tab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07139886

DA9601_GAS_IIb

Details and patient eligibility

About

This is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks.

Enrollment: 212 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are diagnosed with acute gastritis and chronic gastritis by endoscopy; have gastric mucosal lesions such as erosion, bleeding, redness, swelling on the site; and have subjective and objective symptoms requiring medical treatment ② 18 years old or older, 75 years old or younger ③ Patients who have agreed with the terms of clinical trials

Exclusion criteria

• Patients with peptic ulcer (excluding scars) and reflux esophagitis

  • Patients who were administered with H2 antagonist, muscarine receptor antagonist or nonsteroidal anti-inflammatory drug within 2 weeks prior to the start of the trial

    • Patients using protective agent enhancers at the start of the trial ④ Patients with recurrence observed during maintenance therapy at the start of the trial

      • Patients with a history of gastrectomy

        • Patients with severe disorders of the liver, kidneys, heart, lungs, blood, etc. ⑦ Patients with duodenal ulcer ⑧ Patients with gastrointestinal malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

administered 2 tablets of placebo three times daily for two weeks

Treatment:

Drug: Stillen® Tab Placebo

DA-9601(Stillen®) 180mg

Experimental group

Description:

administered 1 tablet of placebo and 1 tablet of DA-9601(Stillen®) three times daily for two weeks

Treatment:

Drug: Stillen® Tab

Drug: Stillen® Tab Placebo

DA-9601(Stillen®) 360mg

Experimental group

Description:

administered 2 tablets of DA-9601(Stillen®) three times daily for two weeks

Treatment:

Drug: Stillen® Tab