Acute GastritisPhase 3NCT01813812
A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
A Phase 3 study testing DA-6034 and Rebamipide 300mg in people with Acute Gastritis and Chronic Gastritis, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Gastritis, Chronic Gastritis
- What is being tested?
- DA-6034 and Rebamipide 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Aug 2013
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with acute gastritis or chronic gastritis
- 1 or more erosions found in the gastroscope examination
- Age should be: 20≤age≤75
Who cannot join
- A patient with peptic ulcer and a gastroesophageal reflux disease.
- Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation
- Had a surgery regarding gastroesophageal
- A patient with Zollinger-Ellison syndrome
- Had a medical history of a malignant tumor
- A patient who is currently taking anti-thrombotic drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Hyun Chae Jung, M.D., Ph.D., 82-2-2072-0694, snuhirb@gmail.com
About this study
Official title: A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034 Compared With Rebamipide in Patients With Acute or Chronic Gastritis
This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- DA-6034, Rebamipide 300mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-6034Drug
Rebamipide 300mgDrug
| Study group | Role | What they receive |
|---|---|---|
| DA-6034 45mg | Experimental | two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day. Receives: Drug: DA-6034 |
| DA-6034 90mg | Experimental | two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day. Receives: Drug: DA-6034 |
| Rebamipide 300mg | Active comparator | two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day. Receives: Drug: Rebamipide 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).
The scale is classified into 5 steps which are based on the severity of the improvement.
EX) noticable improvement: 4->1, 3->1, slight improvement: 4->3, 3->2
Measured: 2 weeks
Secondary outcomes (2)
The number of erosions diagnosed by the gastroscope
Measured: 2 weeks
The severity of the digestive symptoms (Scale of 1 to 5)
the example of the symptoms are:
epigastralgia, heartburn, acid reflux, nausea, domperidone
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startOct 2010
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyun Chae Jung, M.D., Ph.D., Principal investigator, Seoul National University HospitalSoo Heon Park, M.D., Ph.D., Principal investigator, Catholic University Yeouido St. Mary's HopspitalSeong Woo Jeon, M.D., Ph.D., Principal investigator, Kyungpook National University HospitalSang Woo Lee, M.D.,Ph.D., Principal investigator, Korea University Ansan HospitalDong Ho Lee, M.D.,Ph.D., Principal investigator, Seoul National University Bundang HospitalKook Lae Lee, M.D., Ph.D., Principal investigator, SMG-SNU Boramae Medical CenterJu Yung Cho, M.D., Ph.D., Principal investigator, Soonchunhyang University HospitalKi Myeong Lee, M.D., Ph.D., Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813812
- Sponsor's protocol ID
- DA6034_Gas_III (Version 4.3)
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034 Compared With Rebamipide in Patients With Acute or Chronic Gastritis
- ClinicalTrials.gov ID
- NCT01813812
- Acronym / sponsor ID
- DA6034_Gas_III (Version 4.3)
- Conditions
- Acute Gastritis, Chronic Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2013 (estimated)
- First posted
- 19 Mar 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 multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DA-6034 45mg | Experimental | Drug: DA-6034two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day. |
| DA-6034 90mg | Experimental | Drug: DA-6034two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day. |
| Rebamipide 300mg | Active comparator | Drug: Rebamipide 300mgtwo tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with acute gastritis or chronic gastritis
- 1 or more erosions found in the gastroscope examination
- Age should be: 20≤age≤75
Key exclusion criteria (6 listed)
- A patient with peptic ulcer and a gastroesophageal reflux disease.
- Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation
- Had a surgery regarding gastroesophageal
- A patient with Zollinger-Ellison syndrome
- Had a medical history of a malignant tumor
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 |
|---|---|---|
| DA-6034 | Drug | DA-6034 45mg, DA-6034 90mg |
| Rebamipide 300mg | Drug | Rebamipide 300mg |
Primary outcome
The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).
Time frame: 2 weeks
The scale is classified into 5 steps which are based on the severity of the improvement. EX) noticable improvement: 4->1, 3->1, slight improvement: 4->3, 3->2
2 secondary outcomes
The number of erosions diagnosed by the gastroscope
Time frame: 2 weeks
The severity of the digestive symptoms (Scale of 1 to 5)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
Related trials for Acute Gastritis
Not yet recruitingPhase 4
Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis
Gastritis, Acute Gastritis
RecruitingObservational study
Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis
Gastritis
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.
Hyun Chae Jung, M.D., Ph.D. principal investigator
Seoul National University Hospital
Soo Heon Park, M.D., Ph.D. principal investigator
Catholic University Yeouido St. Mary's Hopspital
Seong Woo Jeon, M.D., Ph.D. principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-6034 and Rebamipide 300mg in people with Acute Gastritis and Chronic Gastritis, run by Dong-A Pharmaceutical 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Mar 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Chae Jung, M.D., Ph.D. (82-2-2072-0694, snuhirb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal). (time frame: 2 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 22 Mar 2013.