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

Phase 4

Completed

• Conditions: NSAID-associated Gastroduodenal Injury
• Interventions: Drug: Cytotec (reference drug); Drug: Stillen; Drug: NSAID (Aceclofenac)

• Registration Number: NCT01912066
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-29
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytotec	Cytotec (reference drug)	The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID
Stillen	Stillen	Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID
Stillen	NSAID (Aceclofenac)	Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID
Cytotec	NSAID (Aceclofenac)	The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID

Primary Outcome Measures

Name	Time	Method
the percentage of protected subjects (%)	4 weeks	the definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy.

Secondary Outcome Measures

Name	Time	Method
A percentage of a protected subject (at duodenum), and of ulcer occurrence	4 weeks	1. The definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at duodenum by the endoscopy.; 2. A percentage of ulcer occurrence

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of