GastritisPhase 3NCT03184415
Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients With Gastritis
A Phase 3 study testing DWC20155 and DWC20156 in people with Gastritis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastritis
- What is being tested?
- DWC20155 and DWC20156
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2017to 17 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male of female of at least 19 years old
- Patients diagnosed with acute or chronic gastritis by gastroscopy
- Patients with one or more erosions found by gastroscopy
Who cannot join
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Randomized, Parallel, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy With DWC20155 or DWC20156 Monotherapy in Patients With Gastritis
THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis
- Conditions
- Gastritis
- Being tested
- DWC20155, DWC20156, placebo of DWC20155, placebo of DWC20156
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWC20155Drug
tablet
DWC20156Drug
tablet
placebo of DWC20155Drug
tablet
placebo of DWC20156Drug
tablet
| Study group | Role | What they receive |
|---|---|---|
| DWC20155/DWC20156 Combination Therapy | Experimental | Not described Receives: Drug: DWC20155; Drug: DWC20156; Drug: placebo of DWC20155 |
| DWC20155 Monotherapy | Active comparator | Not described Receives: Drug: DWC20155; Drug: placebo of DWC20155; Drug: placebo of DWC20156 |
| DWC20156 Monotherapy | Active comparator | Not described Receives: Drug: DWC20156; Drug: placebo of DWC20155 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rates of stomach erosions by the endoscopy
Measured: At 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start3 Jul 2017
- Primary completion17 May 2018
- Study completion17 May 2018
Why it stopped: lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184415
- Sponsor's protocol ID
- DW_DWJ1366006
- Status last verified
- Jun 2019
- First submitted
- 9 Jun 2017
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Parallel, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy With DWC20155 or DWC20156 Monotherapy in Patients With Gastritis
- ClinicalTrials.gov ID
- NCT03184415
- Acronym / sponsor ID
- DW_DWJ1366006
- Conditions
- Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 12 Jun 2017 (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.
THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with Gastritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DWC20155/DWC20156 Combination Therapy | Experimental | Drug: DWC20155, Drug: DWC20156, Drug: placebo of DWC20155 |
| DWC20155 Monotherapy | Active comparator | Drug: DWC20155, Drug: placebo of DWC20155, Drug: placebo of DWC20156 |
| DWC20156 Monotherapy | Active comparator | Drug: DWC20156, Drug: placebo of DWC20155 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male of female of at least 19 years old
- Patients diagnosed with acute or chronic gastritis by gastroscopy
- Patients with one or more erosions found by gastroscopy
Key exclusion criteria (3 listed)
- Patients with peptic ulcer and gastroesophageal reflux disease
- Patients with previous gastrointestinal surgery
- Patients with history of gastrointestinal cancer
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 |
|---|---|---|
| DWC20155tablet | Drug | DWC20155 Monotherapy, DWC20155/DWC20156 Combination Therapy |
| DWC20156tablet | Drug | DWC20155/DWC20156 Combination Therapy, DWC20156 Monotherapy |
| placebo of DWC20155tablet | Drug | DWC20155 Monotherapy, DWC20155/DWC20156 Combination Therapy, DWC20156 Monotherapy |
| placebo of DWC20156tablet | Drug | DWC20155 Monotherapy |
Primary outcome
Improvement rates of stomach erosions by the endoscopy
Time frame: At 2 weeks
Results and safety
The study was stopped early (reason given: lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
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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.
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 DWC20155 and DWC20156 in people with Gastritis, run by Daewoong 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 3 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: stopped early, as of the sponsor's last update on 26 Jun 2019. 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?
The study was stopped early (reason given: lack of efficacy). 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?
Improvement rates of stomach erosions by the endoscopy (time frame: At 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 26 Jun 2019.