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

NCT ID: NCT02386007

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Acute and Chronic Gastric Inflammation Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DW-3101_150mg

150mg a day

Group Type EXPERIMENTAL

DW-3101_150mg

Intervention Type DRUG

DW-3101_300mg

300mg a day

Group Type EXPERIMENTAL

DW-3101_300mg

Intervention Type DRUG

DW-3101_600mg

600mg a day

Group Type EXPERIMENTAL

DW-3101_600mg

Intervention Type DRUG

a tablet same as experimental agents in formation and shape

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DW-3101_150mg

Intervention Type DRUG

DW-3101_300mg

Intervention Type DRUG

DW-3101_600mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW 3101_201

Identifier Type: -

Identifier Source: org_study_id

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