Acute and Chronic Gastric Inflammation PatientsPhase 2NCT02386007
Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients
A Phase 2 study testing DW-3101_150mg, DW-3101_300mg and DW-3101_600mg in people with Acute and Chronic Gastric Inflammation Patients, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute and Chronic Gastric Inflammation Patients
- What is being tested?
- DW-3101_150mg, DW-3101_300mg and DW-3101_600mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2017
- Phase
- Phase 2
- 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
- Adult males/females aged 20~75 years
- Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents
- Subjects who voluntarily agree to participate in this clinical test with written consent
Who cannot join
- Patients impossible gastroscopy
- In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis
- Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded)
- Patients with malignant tumor on digestive organ
- Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)
About this study
Official title: A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation
The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.
- Being tested
- DW-3101_150mg, DW-3101_300mg, DW-3101_600mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW-3101_150mgDrug
DW-3101_300mgDrug
DW-3101_600mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DW-3101_150mg | Experimental | 150mg a day Receives: Drug: DW-3101_150mg |
| DW-3101_300mg | Experimental | 300mg a day Receives: Drug: DW-3101_300mg |
| DW-3101_600mg | Experimental | 600mg a day Receives: Drug: DW-3101_600mg |
| a tablet same as experimental agents in formation and shape | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of gastric erosion score
The erosion score is evaluated by gastroscopy. Erosion score The number of erosion
- 0
- 1~2
- 3~5
- More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness.
Measured: 14day±3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute and Chronic Gastric Inflammation PatientsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
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
- NCT02386007
- Sponsor's protocol ID
- DW 3101_201
- Status last verified
- Oct 2016
- First submitted
- 16 Feb 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation
- ClinicalTrials.gov ID
- NCT02386007
- Acronym / sponsor ID
- DW 3101_201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Jul 2017 (estimated)
- First posted
- 11 Mar 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 to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DW-3101_150mg | Experimental | Drug: DW-3101_150mg150mg a day |
| DW-3101_300mg | Experimental | Drug: DW-3101_300mg300mg a day |
| DW-3101_600mg | Experimental | Drug: DW-3101_600mg600mg a day |
| a tablet same as experimental agents in formation and shape | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males/females aged 20~75 years
- Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents
- Subjects who voluntarily agree to participate in this clinical test with written consent
Key exclusion criteria (5 listed)
- Patients impossible gastroscopy
- In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis
- Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded)
- Patients with malignant tumor on digestive organ
- Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)
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 |
|---|---|---|
| DW-3101_150mg | Drug | DW-3101_150mg |
| DW-3101_300mg | Drug | DW-3101_300mg |
| DW-3101_600mg | Drug | DW-3101_600mg |
| Placebo | Drug | a tablet same as experimental agents in formation and shape |
Primary outcome
The change of gastric erosion score
Time frame: 14day±3
The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 1. 0 2. 1~2 3. 3~5 4. More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
Related trials for Acute and Chronic Gastric Inflammation Patients
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.
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 2 study testing DW-3101_150mg, DW-3101_300mg and DW-3101_600mg in people with Acute and Chronic Gastric Inflammation Patients, 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 5 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 12 Oct 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The change of gastric erosion score (time frame: 14day±3). 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 12 Oct 2016.