NSAID-associated Gastroduodenal InjuryPhase 4NCT01912066
A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601
A Phase 4 study testing Stillen, Cytotec (reference drug) and NSAID (Aceclofenac) in people with NSAID-associated Gastroduodenal Injury, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- NSAID-associated Gastroduodenal Injury
- What is being tested?
- Stillen, Cytotec (reference drug) and NSAID (Aceclofenac)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Need to take NSAID pills for longer than four weeks
- should be normal diagnosed by the endoscopy test
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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
- Being tested
- Stillen, Cytotec (reference drug), NSAID (Aceclofenac)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StillenDrug
Cytotec (reference drug)Drug
NSAID (Aceclofenac)Drug
| Study group | Role | What they receive |
|---|---|---|
| Stillen | Experimental | Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID Receives: Drug: Stillen; Drug: NSAID (Aceclofenac) |
| Cytotec | Active comparator | The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID Receives: Drug: Cytotec (reference drug); Drug: NSAID (Aceclofenac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of protected subjects (%)
the definition of "protected" is the subjects with no erosions, in other words, either zero or 1 erosion found at stomach by the endoscopy.
Measured: 4 weeks
Secondary outcomes (1)
A percentage of a protected subject (at duodenum), and of ulcer occurrence
- 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAID-associated Gastroduodenal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang-Yong Seol, MD, Study chair, Inje UniversityMyoung-Gyu Choi, MD, Principal investigator, The Catholic University of KoreaOh Young Lee, MD, Principal investigator, Hanyang UniversityDong Ho Lee, MD, Principal investigator, Seoul National University Bundang HospitalYong Chan Lee, MD, Principal investigator, Severance HospitalSuck Chei Choi, MD, Principal investigator, Wonkwang University School of Medicine & HospitalJong Sun Rew, MD, Principal investigator, Chonnam National University HospitalKang Moon Lee, Principal investigator, Saint Vincent's Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912066
- Sponsor's protocol ID
- DA9601_PG_IV
- Status last verified
- Sep 2014
- First submitted
- 25 Jul 2013
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01912066
- Acronym / sponsor ID
- DA9601_PG_IV
- Conditions
- NSAID-associated Gastroduodenal Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stillen | Experimental | Drug: Stillen, Drug: NSAID (Aceclofenac)Patients taking a tab of Stillen and a tab of placebo drug and a tab of NSAID |
| Cytotec | Active comparator | Drug: Cytotec (reference drug), Drug: NSAID (Aceclofenac)The subjects taking a tab of Cytotec, a tab of placebo drug, and a tab of NSAID |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Need to take NSAID pills for longer than four weeks
- should be normal diagnosed by the endoscopy test
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stillen | Drug | Stillen |
| Cytotec (reference drug) | Drug | Cytotec |
| NSAID (Aceclofenac) | Drug | Cytotec, Stillen |
Primary outcome
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.
1 secondary outcome
A percentage of a protected subject (at duodenum), and of ulcer occurrence
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Yong Seol, MD study chair
Inje University
Myoung-Gyu Choi, MD principal investigator
The Catholic University of Korea
Oh Young Lee, MD principal investigator
Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stillen, Cytotec (reference drug) and NSAID (Aceclofenac) in people with NSAID-associated Gastroduodenal Injury, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of protected subjects (%) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014; AzTrials last refreshed its copy on 27 Oct 2026.