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

Dong-A ST

Status and phase: Completed; Phase 4

Conditions: NSAID-associated Gastroduodenal Injury

Treatments: Drug: NSAID (Aceclofenac); Drug: Stillen; Drug: Cytotec (reference drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01912066

DA9601_PG_IV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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520 participants in 2 patient groups

Stillen

Experimental group

Description:

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

Treatment:

Drug: Stillen

Drug: NSAID (Aceclofenac)

Cytotec

Active Comparator group

Description:

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

Treatment:

Drug: Cytotec (reference drug)

Drug: NSAID (Aceclofenac)