Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients

Daewon Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Acute and Chronic Gastric Inflammation Patients

Treatments: Drug: DW-3101_150mg; Drug: DW-3101_300mg; Drug: Placebo; Drug: DW-3101_600mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02386007

DW 3101_201

Details and patient eligibility

About

The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult males/females aged 20~75 years
• Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents
• Subjects who voluntarily agree to participate in this clinical test with written consent

Exclusion criteria

• Patients impossible gastroscopy
• In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis
• Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded)
• Patients with malignant tumor on digestive organ
• Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 4 patient groups, including a placebo group

DW-3101_150mg

Experimental group

Description:

150mg a day

Treatment:

Drug: DW-3101_150mg

DW-3101_300mg

Experimental group

Description:

300mg a day

Treatment:

Drug: DW-3101_300mg

DW-3101_600mg

Experimental group

Description:

600mg a day

Treatment:

Drug: DW-3101_600mg

a tablet same as experimental agents in formation and shape

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo