Acute GastritisPhase 3NCT04341454
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
A Phase 3 study testing DWP14012 X mg and DWP14012 Y mg in people with Acute Gastritis and Chronic Gastritis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo 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
- Acute Gastritis, Chronic Gastritis
- What is being tested?
- DWP14012 X mg and DWP14012 Y mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2020to 16 Sep 2021
- 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
- Adults between 19 and 75 years old based on the date of written agreement
- Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
- Those who had experienced one or more subjective symptoms of gastritis
Who cannot join
- Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
- Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis
Read the detailed description
This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- DWP14012 X mg, DWP14012 X mg placebo, DWP14012 Y mg, DWP14012 Y mg placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 X mgDrug
DWP14012 X mg, tablet, orally, once daily for 2 weeks
DWP14012 X mg placeboDrug
DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks
DWP14012 Y mgDrug
DWP14012 Y mg, tablet, orally, twice daily for 2 weeks
DWP14012 Y mg placeboDrug
DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| DWP14012 X mg QD | Experimental | * Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo
* Evening: 1 tablet of DWP14012 Y mg placebo Receives: Drug: DWP14012 X mg; Drug: DWP14012 Y mg placebo |
| DWP14012 Y mg BID | Experimental | * Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg
* Evening: 1 tablet of DWP14012 Y mg Receives: Drug: DWP14012 X mg placebo; Drug: DWP14012 Y mg |
| placebo | Placebo comparator | * Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo
* Evening: 1 tablet of DWP14012 Y mg placebo Receives: Drug: DWP14012 X mg placebo; Drug: DWP14012 Y mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate of gastric mucosal erosion
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100
Measured: at 2 weeks after the IP administration
Secondary outcomes (5)
Cure rate of gastric mucosal erosion
Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100
Measured: at 2 weeks after the IP administration
Cure rate of gastric mucosal edema
Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100
Measured: at 2 weeks after the IP administration
Improvement rate of gastric mucosal erythema
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100
Measured: at 2 weeks after the IP administration
Improvement rate of gastric mucosal bleeding
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100
Measured: at 2 weeks after the IP administration
Improvement rate of subjective symptoms
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100
Measured: at 2 weeks after the IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start2 Jun 2020
- Primary completion4 Aug 2021
- Study completion16 Sep 2021
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.
- 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
- 327 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
- NCT04341454
- Sponsor's protocol ID
- DW_DWP14012305
- Status last verified
- Dec 2021
- First submitted
- 9 Apr 2020
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15.
PubMed 36789577
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis
- ClinicalTrials.gov ID
- NCT04341454
- Acronym / sponsor ID
- DW_DWP14012305
- Conditions
- Acute Gastritis, Chronic Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 10 Apr 2020 (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 study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis
Detailed description
This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DWP14012 X mg QD | Experimental | Drug: DWP14012 X mg, Drug: DWP14012 Y mg placebo* Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo |
| DWP14012 Y mg BID | Experimental | Drug: DWP14012 X mg placebo, Drug: DWP14012 Y mg* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg * Evening: 1 tablet of DWP14012 Y mg |
| placebo | Placebo comparator | Drug: DWP14012 X mg placebo, Drug: DWP14012 Y mg placebo* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between 19 and 75 years old based on the date of written agreement
- Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
- Those who had experienced one or more subjective symptoms of gastritis
Key exclusion criteria (2 listed)
- Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
- Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results
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 |
|---|---|---|
| DWP14012 X mgDWP14012 X mg, tablet, orally, once daily for 2 weeks | Drug | DWP14012 X mg QD |
| DWP14012 X mg placeboDWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks | Drug | DWP14012 Y mg BID, placebo |
| DWP14012 Y mgDWP14012 Y mg, tablet, orally, twice daily for 2 weeks | Drug | DWP14012 Y mg BID |
| DWP14012 Y mg placeboDWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks | Drug | DWP14012 X mg QD, placebo |
Primary outcome
Improvement rate of gastric mucosal erosion
Time frame: at 2 weeks after the IP administration
Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100
5 secondary outcomes
Cure rate of gastric mucosal erosion
Time frame: at 2 weeks after the IP administration
Cure rate of gastric mucosal edema
Time frame: at 2 weeks after the IP administration
Improvement rate of gastric mucosal erythema
Time frame: at 2 weeks after the IP administration
Improvement rate of gastric mucosal bleeding
Time frame: at 2 weeks after the IP administration
Improvement rate of subjective symptoms
Time frame: at 2 weeks after the IP administration
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 21 Dec 2021.
- Derived from this study: PubMed 36789577Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15.
- Individual participant dataSharing planned: No
Related trials for Acute Gastritis
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.
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 DWP14012 X mg and DWP14012 Y mg in people with Acute Gastritis and Chronic 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 2 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 21 Dec 2021. 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. 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 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?
Improvement rate of gastric mucosal erosion (time frame: at 2 weeks after the IP administration). 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 NCT04341454, 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 21 Dec 2021.