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

D

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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