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A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601

NCT ID: NCT01912066

Last Updated: 2014-09-30

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-03-31

Brief Summary

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This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.

Detailed Description

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After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed.

Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.

Conditions

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NSAID-associated Gastroduodenal Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Stillen

Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID

Group Type EXPERIMENTAL

Stillen

Intervention Type DRUG

NSAID (Aceclofenac)

Intervention Type DRUG

Cytotec

The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID

Group Type ACTIVE_COMPARATOR

Cytotec (reference drug)

Intervention Type DRUG

NSAID (Aceclofenac)

Intervention Type DRUG

Interventions

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Stillen

Intervention Type DRUG

Cytotec (reference drug)

Intervention Type DRUG

NSAID (Aceclofenac)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Need to take NSAID pills for longer than four weeks
* should be normal diagnosed by the endoscopy test

Exclusion Criteria

* The patients have gastric ulcer or duodenal ulcer within 30 days
* The patients have a gastro-intestinal surgery within a year
* The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang-Yong Seol, MD

Role: STUDY_CHAIR

Inje University

Myoung-Gyu Choi, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Oh Young Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Dong Ho Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Yong Chan Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Suck Chei Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Wonkwang University School of Medicine & Hospital

Jong Sun Rew, MD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Kang Moon Lee

Role: PRINCIPAL_INVESTIGATOR

Saint Vincent's Hospital, Korea

Jae Young Jang, MD

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University Medical Center

Hoon-jai Chun, MD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Sang-woo Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Korea University Ansan Hospital

Moo In Park, MD

Role: PRINCIPAL_INVESTIGATOR

Kosin University Gospel Hospital

Joong Goo Kwon, MD

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Geunam Song, MD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Seong Woo Jeon, MD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Medical Center

Soo Taek Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Jae Gyu Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Poong-Lyul Rhee, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Kwang Jae Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Hyo Jin Park, MD

Role: PRINCIPAL_INVESTIGATOR

Gangnam Severance Hospital

Byung Ik Jang, MD

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University Hospital

Yong Woon Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Dong Soo Han, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Sung Kook Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA9601_PG_IV

Identifier Type: -

Identifier Source: org_study_id