Acute GastritisPhase 3NCT02282670
A Study to Evaluate the Efficacy and Safety of DA-5204
A Phase 3 study testing DA-5204 and Stillen tab. in people with Acute Gastritis and Chronic Gastritis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. 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-5204 and Stillen tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Nov 2014
- 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
- Age is over 20 years old, under 75 years old, men or women
- Patients diagnosed with acute or chronic gastritis by gastroscopy
- Patients with one or more erosions found by gastroscopy
- Signed the informed consent forms
Who cannot join
- Patients who is impossible to receive gastroscopy
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
- Patients with surgery related to gastroesophageal
- Patients with Zollinger-Ellison syndrome
- Patients with any kind of malignant tumor
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- Patients administered with anti-thrombotic drugs
- Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
- Patients with neuropsychiatric disorder, alcoholism, or drug abuse
- Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
- Women either pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Universtiy, Bundang Hospital, IRB
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5204 and to Demonstrate the Non-inferiority of DA-5204 Compared With Stillen Tab. in Patients With Acute or Chronic Gastritis
This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- DA-5204, Stillen tab.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5204Drug
Stillen tab.Drug
| Study group | Role | What they receive |
|---|---|---|
| DA-5204 | Experimental | DA-5204 administered two times daily for two weeks Receives: Drug: DA-5204 |
| Stillen tab. | Active comparator | Stillen tab. administered three times daily for two weeks Receives: Drug: Stillen tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
The definition of "moderate improvement" is the subjects showed score changed from 4 to 1 or from 2 to 1. And, "significant improvement" means the subject showed score changed from 4 to 1 or from 3 to 1.
[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
Measured: 2 weeks
Secondary outcomes (2)
A percentage of completely cured subject after a treatment
The definition of "completely cured" is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy.
Measured: 2 weeks
A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.
The definition of "moderate improvement" is the subjects showed reduction ratio of score changed from 50% to 75%. And, "singnificant improvement" means the subjects showed reduction ratio of score changed 75% or more. Reduction ratio of score is calculated as [1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)].
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 posted4 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Ho Lee, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital of KoreaMyung Gyu Choi, M.D., Ph.D., Principal investigator, The Catholic University, Seoul St. Mary's Hospital of KoreaSung Joon Lee, M.D., Ph.D., Principal investigator, Kangwon National University Hospital of KoreaSung Kuk Kim, M.D., Ph.D., Principal investigator, Kyungbuk National University Hospital of KoreaGeun Am Song, M.D., Ph.D., Principal investigator, Pusan National Universtiy Hospital of KoreaPoong Lyeol Lee, M.D., Ph.D., Principal investigator, Samsung Medical Center of KoreaHwoon Yong Jung, M.D., Ph.D., Principal investigator, Asan Medical Center of KoreaDae Hwan Kang, M.D., Ph.D., Principal investigator, Pusan National University Yangsan Hospital of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282670
- Sponsor's protocol ID
- DA5204_GR_III
- Status last verified
- Oct 2014
- First submitted
- 28 Oct 2014
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi YJ, Lee DH, Choi MG, Lee SJ, Kim SK, Song GA, Rhee PL, Jung HY, Kang DH, Lee YC, Lee SH, Choi SC, Shim KN, Seol SY, Moon JS, Shin YW, Kim HS, Lee ST, Cho JW, Choi EK, Lee OY, Jang JS. Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study. J Korean Med Sci. 2017 Nov;32(11):1807-1813. doi: 10.3346/jkms.2017.32.11.1807.
PubMed 28960033
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5204 and to Demonstrate the Non-inferiority of DA-5204 Compared With Stillen Tab. in Patients With Acute or Chronic Gastritis
- ClinicalTrials.gov ID
- NCT02282670
- Acronym / sponsor ID
- DA5204_GR_III
- Conditions
- Acute Gastritis, Chronic Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 4 Nov 2014 (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, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-5204 | Experimental | Drug: DA-5204DA-5204 administered two times daily for two weeks |
| Stillen tab. | Active comparator | Drug: Stillen tab.Stillen tab. administered three times daily for two weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age is over 20 years old, under 75 years old, men or women
- Patients diagnosed with acute or chronic gastritis by gastroscopy
- Patients with one or more erosions found by gastroscopy
- Signed the informed consent forms
Key exclusion criteria (11 listed)
- Patients who is impossible to receive gastroscopy
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
- Patients with surgery related to gastroesophageal
- Patients with Zollinger-Ellison syndrome
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-5204 | Drug | DA-5204 |
| Stillen tab. | Drug | Stillen tab. |
Primary outcome
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
Time frame: 2 weeks
The definition of "moderate improvement" is the subjects showed score changed from 4 to 1 or from 2 to 1. And, "significant improvement" means the subject showed score changed from 4 to 1 or from 3 to 1. [score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions]
2 secondary outcomes
A percentage of completely cured subject after a treatment
Time frame: 2 weeks
A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.
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 4 Nov 2014.
- Derived from this study: PubMed 28960033Choi YJ, Lee DH, Choi MG, Lee SJ, Kim SK, Song GA, Rhee PL, Jung HY, Kang DH, Lee YC, Lee SH, Choi SC, Shim KN, Seol SY, Moon JS, Shin YW, Kim HS, Lee ST, Cho JW, Choi EK, Lee OY, Jang JS. Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study. J Korean Med Sci. 2017 Nov;32(11):1807-1813. doi: 10.3346/jkms.2017.32.11.1807.
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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.
Dong Ho Lee, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital of Korea
Myung Gyu Choi, M.D., Ph.D. principal investigator
The Catholic University, Seoul St. Mary's Hospital of Korea
Sung Joon Lee, M.D., Ph.D. principal investigator
Kangwon National University Hospital of Korea
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-5204 and Stillen tab. in people with Acute Gastritis and Chronic Gastritis, 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 4 inclusion and 11 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 4 Nov 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 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?
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?
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02282670, which also lists 1 linked publication.
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 4 Nov 2014.