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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01912066

Enrollment

520

Registered

2013-07-30

Start date

2012-09-30

Completion date

2014-03-31

Last updated

2014-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSAID-associated Gastroduodenal Injury

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.

Interventions

DRUGStillen

DRUGCytotec (reference drug)

DRUGNSAID (Aceclofenac)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026