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Completed

NCT Number: NCT01912066

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

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.

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Key information

Conditions

NSAID-associated Gastroduodenal Injury

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inje University Busan Paik Hospital

Busan, 614735, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stillen

Drug

Cytotec (reference drug)

Drug

NSAID (Aceclofenac)

Drug

Primary outcomes

  1. the percentage of protected subjects (%)

    Time frame: 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 outcomes

  1. A percentage of a protected subject (at duodenum), and of ulcer occurrence

    Time frame: 4 weeks

    • The definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at duodenum by the endoscopy.
    • A percentage of ulcer occurrence

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Sep 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.