Acute GastritisPhase 4NCT02356679
Efficacy and Safety of Eupasidin-s Tab.(EUPASIDIN-S) in Gastritis Patients
A Phase 4 study testing Eupasidin-s Tab and Stillen Tab. in people with Acute Gastritis and Chronic Gastritis, run by Chong Kun Dang Pharmaceutical at 10 sites in South Korea.
Trial summary
The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Gastritis, Chronic Gastritis
- What is being tested?
- Eupasidin-s Tab and Stillen Tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Aug 2014to Jun 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age is 19 years old and over, men or women
- Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms
- Patients with one or more erosions found by gastroscopy
- Patients who voluntarily signed written informed consent may participate in the study
Who cannot join
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with Gastrointestinal malignant tumor or surgery related to stomach resection
- Patients with thromboembolism and coagulation disorder
- Patients with significant cardiovascular, pulmonary, heptic, renal primary disease
- Patients with abnormal laboratory result at screening
- Aspartate aminotransferase(AST), Alanine aminotransferase(ALT), Creatinine > upper limit of normal range x 2
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- White blood cell(WBC) < 4,000/mm3
- Platelet < 50,000/mm3
- Patients administered with H2 receptor antagonists, proton pump inhibitors, muscarine receptor antagonists, other gastiritis treatment drug, protective factor builder, non-steroid anti-inflammatory drugs prior to study in 2 weeks
- History of allergic reaction to the investigational product
- Women either pregnant, breast feeding or possible to pregnant without contraceptive method
- Use of other investigational drugs within 3 months prior to the study
- Patients that investigators consider ineligible for this study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Inje University Busanpaik hospital
Busan, Busangjin, 614-735
Kosin University Gospel Hospital
Busan, Seo-gu, 602-702
Dong-A University Hospital
Busan, Seo-gu, 602-812
Yeungnam University Medical Center
Daegu, Nam-gu, 705-703
Chungnam National University Hospital
Daejeon, Jung-gu, 301-721
Chonnam National University Hospital
Guangju, Dong-gu, 501-757
Wonkwang University School of Medicine & Hospital
Iksan, Muwang-ro, 570-711
Chonbuk National University Hospital
Jeonju, Deokjin-gu, 561-712
Hanyang University Medical Center
Seoul, Seongdong-gu, 133-792
Wonju Severance Christian Hospital
Wŏnju, Ilsan-ro, 220-701
About this study
Official title: A Phase 4, Multicenter, Randomized, Open, Active Drug Comparative Trial to Evaluated the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients
The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients.
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- Eupasidin-s Tab, Stillen Tab.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eupasidin-s TabDrug
Also called Artemisia herb isopropanol soft ext. 60mg
three times per day, 1 tab for each time, PO, during 2weeks
Stillen Tab.Drug
Also called Artemisia asiatica 95% ethanol ext. 60mg
three times per day, 1 tab for each time, PO, during 2weeks
| Study group | Role | What they receive |
|---|---|---|
| Eupasidin-s tab. | Experimental | three times per day, 1 tab for each time, PO, during 2weeks Receives: Drug: Eupasidin-s Tab |
| Stillen tab. | Active comparator | three times per day, 1 tab for each time, PO, during 2weeks Receives: Drug: Stillen Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate of erosion
Measured: 2 weeks
Secondary outcomes (5)
improvement rate of erosion
Measured: 2 weeks
improvement rate of erythema
Measured: 2 weeks
improvement rate of hemorrhage
Measured: 2 weeks
improvement rate of edema
Measured: 2 weeks
improvement rate of self symptoms
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 posted5 Feb 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionJun 2015
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.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sangyong Seol, Professor, Principal investigator, Inje University Busanpaik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356679
- Sponsor's protocol ID
- EUPASIDIN-S_P4
- Status last verified
- Aug 2015
- First submitted
- 2 Sep 2014
- Last updated
- 24 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Multicenter, Randomized, Open, Active Drug Comparative Trial to Evaluated the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients
- ClinicalTrials.gov ID
- NCT02356679
- Acronym / sponsor ID
- EUPASIDIN-S_P4
- Conditions
- Acute Gastritis, Chronic Gastritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Feb 2015 (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.
The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eupasidin-s tab. | Experimental | Drug: Eupasidin-s Tabthree times per day, 1 tab for each time, PO, during 2weeks |
| Stillen tab. | Active comparator | Drug: Stillen Tab.three times per day, 1 tab for each time, PO, during 2weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age is 19 years old and over, men or women
- Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms
- Patients with one or more erosions found by gastroscopy
- Patients who voluntarily signed written informed consent may participate in the study
Key exclusion criteria (13 listed)
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with Gastrointestinal malignant tumor or surgery related to stomach resection
- Patients with thromboembolism and coagulation disorder
- Patients with significant cardiovascular, pulmonary, heptic, renal primary disease
- Patients with abnormal laboratory result at screening
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 |
|---|---|---|
| Eupasidin-s TabAlso: Artemisia herb isopropanol soft ext. 60mgthree times per day, 1 tab for each time, PO, during 2weeks | Drug | Eupasidin-s tab. |
| Stillen Tab.Also: Artemisia asiatica 95% ethanol ext. 60mgthree times per day, 1 tab for each time, PO, during 2weeks | Drug | Stillen tab. |
Primary outcome
cure rate of erosion
Time frame: 2 weeks
5 secondary outcomes
improvement rate of erosion
Time frame: 2 weeks
improvement rate of erythema
Time frame: 2 weeks
improvement rate of hemorrhage
Time frame: 2 weeks
improvement rate of edema
Time frame: 2 weeks
improvement rate of self symptoms
Time frame: 2 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 24 Aug 2015.
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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.
Sangyong Seol, Professor principal investigator
Inje University Busanpaik Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eupasidin-s Tab and Stillen Tab. in people with Acute Gastritis and Chronic Gastritis, run by Chong Kun Dang Pharmaceutical at 10 sites 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 13 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 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
cure rate of erosion (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 24 Aug 2015.