Gastritis AcutePhase 32NCT03443804
To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
A Phase 3 study testing Test(DW1401) and Reference(Stillen tab.) in people with Gastritis Acute and Gastritis Chronic, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastritis Acute, Gastritis Chronic
- What is being tested?
- Test(DW1401) and Reference(Stillen tab.)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- No sites listed yet
- Study dates
- Jul 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
- At least one or more erosions have been identified on gastroscopy.
- Patients who decided to voluntarily participate in this trial and agreed in writing.
Who cannot join
- Patients who can not undergo gastroscopy
- Peptic ulcer (except scarring) and reflux esophagitis
- Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
- Patients with a history of gastrointestinal malignancies
- Zollinger-Ellison syndrome patients
- Patient with spontaneous coagulation disorder
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- Patients with an allergic or hypersensitive response to a study drug
- Patients with a potential pregnancy.
- Patients who had clinically significant abnormalities in the screening test. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit)
- Pregnant and lactating women
- Those currently taking other study drugs
- patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.
About this study
Official title: A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis
- Conditions
- Gastritis Acute, Gastritis Chronic
- Being tested
- Test(DW1401), Reference(Stillen tab.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test(DW1401)Drug
DW1401+Placebo of Stillen tab.
Reference(Stillen tab.)Drug
Stillen tab.+Placebo of DW1401
| Study group | Role | What they receive |
|---|---|---|
| Test(DW1401) | Experimental | tid PO, DW1401+Placebo of Stillen tab. Receives: Drug: Test(DW1401) |
| Reference(Stillen tab.) | Active comparator | tid PO, Stillen tab.+Placebo of DW1401 Receives: Drug: Reference(Stillen tab.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy rate on gastroscopy
The efficacy rate is obtained from the following formula using the subject whose erroneous score is improved by 50% or more as compared with before the study drug administration.
The efficacy rate(%) = (number of effective cases)/(all cases) x 100
Effective case is determined by the grade change of erosion. A case in which the grade changes from 4 to 2 or 1, from 3 to 1, or from 2 to 1 is judged as an effective case.
Measured: 0, week 2
Secondary outcomes (1)
Cure rate on gastroscopy
Judging from the gastroscopic examination as normal (no erosion), the cure rate is obtained as follows.
Cure rate(%) = (number of cures(no erosion))/(all cases) x 100
Measured: 0, week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastritis AcuteStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443804
- Sponsor's protocol ID
- DW1401-302
- Acronym
- 2
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for IPD.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
- ClinicalTrials.gov ID
- NCT03443804
- Acronym / sponsor ID
- 2 / DW1401-302
- Conditions
- Gastritis Acute, Gastritis Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Feb 2018 (actual)
- 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.
Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test(DW1401) | Experimental | Drug: Test(DW1401)tid PO, DW1401+Placebo of Stillen tab. |
| Reference(Stillen tab.) | Active comparator | Drug: Reference(Stillen tab.)tid PO, Stillen tab.+Placebo of DW1401 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
- At least one or more erosions have been identified on gastroscopy.
- Patients who decided to voluntarily participate in this trial and agreed in writing.
Key exclusion criteria (12 listed)
- Patients who can not undergo gastroscopy
- Peptic ulcer (except scarring) and reflux esophagitis
- Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
- Patients with a history of gastrointestinal malignancies
- Zollinger-Ellison syndrome patients
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 |
|---|---|---|
| Test(DW1401)DW1401+Placebo of Stillen tab. | Drug | Test(DW1401) |
| Reference(Stillen tab.)Stillen tab.+Placebo of DW1401 | Drug | Reference(Stillen tab.) |
Primary outcome
The efficacy rate on gastroscopy
Time frame: 0, week 2
The efficacy rate is obtained from the following formula using the subject whose erroneous score is improved by 50% or more as compared with before the study drug administration. The efficacy rate(%) = (number of effective cases)/(all cases) x 100 Effective case is determined by the grade change of erosion. A case in which the grade changes from 4 to 2 or 1, from 3 to 1, or from 2 to 1 is judged as an effective case.
1 secondary outcome
Cure rate on gastroscopy
Time frame: 0, week 2
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 28 Feb 2018.
- Individual participant dataSharing planned: No. There is no plan for IPD.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test(DW1401) and Reference(Stillen tab.) in people with Gastritis Acute and Gastritis Chronic, run by Daewon Pharmaceutical Co., Ltd..
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 12 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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 efficacy rate on gastroscopy (time frame: 0, week 2). 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 28 Feb 2018.