NCT01912066

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• NSAID-associated Gastroduodenal Injury

Interventions

Type	Name	Description
DRUG	Stillen
DRUG	Cytotec (reference drug)
DRUG	NSAID (Aceclofenac)

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-07-30
• Last updated: 2014-09-30

Locations

1 site across 1 country: South Korea