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

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ClinicalTrials.gov Identifier: NCT02386007
Recruitment Status : Unknown
Verified October 2016 by Daewon Pharmaceutical Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : March 11, 2015
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute and Chronic Gastric Inflammation Patients Drug: DW-3101_150mg Drug: DW-3101_300mg Drug: DW-3101_600mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation
Estimated Primary Completion Date : July 2017

Arm Intervention/treatment
Experimental: DW-3101_150mg
150mg a day
Drug: DW-3101_150mg
Experimental: DW-3101_300mg
300mg a day
Drug: DW-3101_300mg
Experimental: DW-3101_600mg
600mg a day
Drug: DW-3101_600mg
Placebo Comparator: a tablet same as experimental agents in formation and shape
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. The change of gastric erosion score [ Time Frame: 14day±3 ]

    The erosion score is evaluated by gastroscopy. Erosion score The number of erosion

    1. 0
    2. 1~2
    3. 3~5
    4. More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02386007     History of Changes
Other Study ID Numbers: DW 3101_201
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Gastritis
Inflammation
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases