Clinical trial NCT01912066: A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601
Official title: A Phase IV Clinical Trial to Evaluate the Preventive Effectiveness of NSAID-Associated Gastroduodenal Injury (Multi-center, Double-blind, Active-controlled, Stratified Randomized, Parallel Group)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: NSAID-associated Gastroduodenal Injury
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 520
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: the percentage of protected subjects (%)
timeFrame: 4 weeks
Secondary outcomes:
measure: A percentage of a protected subject (at duodenum), and of ulcer occurrence
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
affiliation: Inje University
name: Sang-Yong Seol, MD
role: STUDY_CHAIR
affiliation: The Catholic University of Korea
name: Myoung-Gyu Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Oh Young Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Dong Ho Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Yong Chan Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University School of Medicine & Hospital
name: Suck Chei Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Jong Sun Rew, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Vincent's Hospital, Korea
name: Kang Moon Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Medical Center
name: Jae Young Jang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Hoon-jai Chun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Ansan Hospital
name: Sang-woo Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kosin University Gospel Hospital
name: Moo In Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Joong Goo Kwon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Geunam Song, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Medical Center
name: Seong Woo Jeon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Soo Taek Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Jae Gyu Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Poong-Lyul Rhee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Kwang Jae Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangnam Severance Hospital
name: Hyo Jin Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital
name: Byung Ik Jang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Yong Woon Shin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Dong Soo Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Sung Kook Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: