GERDPhase 2NCT04282954
Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
A Phase 2 study testing JP-1366 and Esomeprazole 40mg in people with GERD, run by Onconic Therapeutics Inc. at 1 site in South Korea.
Trial summary
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- GERD
- What is being tested?
- JP-1366 and Esomeprazole 40mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2019to 11 Dec 2020
- 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 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 have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
- Those who experienced symptoms of heartburn or acid reflux within the last 7 days
Who cannot join
- Those who have undergone gastric acid suppression or gastric, esophageal surgery
- Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
- Clinically significant abnormal laboratory values during screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease
- Conditions
- GERD
- Being tested
- JP-1366, JP-1366 placebo, Esomeprazole 40mg, Esomeprazole placebo
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JP-1366Drug
JP-1366, QD
JP-1366 placeboDrug
JP-1366 placebo, QD
Esomeprazole 40mgDrug
Esomeprazole 40mg, QD
Esomeprazole placeboDrug
Esomeprazole placebo, QD
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | JP-1366 A mg Receives: Drug: JP-1366; Drug: JP-1366 placebo; Drug: Esomeprazole placebo |
| Group 2 | Experimental | JP-1366 B mg Receives: Drug: JP-1366; Drug: JP-1366 placebo; Drug: Esomeprazole placebo |
| Group 3 | Experimental | JP-1366 C mg Receives: Drug: JP-1366; Drug: JP-1366 placebo; Drug: Esomeprazole placebo |
| Goup 4 | Active comparator | Esomeprazole 40 mg Receives: Drug: JP-1366 placebo; Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)
- Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start15 Nov 2019
- Primary completion20 Oct 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282954
- Sponsor's protocol ID
- JP-1366-201
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2020
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT04282954
- Acronym / sponsor ID
- JP-1366-201
- Conditions
- GERD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 25 Feb 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.
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: JP-1366, Drug: JP-1366 placebo, Drug: Esomeprazole placeboJP-1366 A mg |
| Group 2 | Experimental | Drug: JP-1366, Drug: JP-1366 placebo, Drug: Esomeprazole placeboJP-1366 B mg |
| Group 3 | Experimental | Drug: JP-1366, Drug: JP-1366 placebo, Drug: Esomeprazole placeboJP-1366 C mg |
| Goup 4 | Active comparator | Drug: JP-1366 placebo, Drug: Esomeprazole 40mgEsomeprazole 40 mg |
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 have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
- Those who experienced symptoms of heartburn or acid reflux within the last 7 days
Key exclusion criteria (3 listed)
- Those who have undergone gastric acid suppression or gastric, esophageal surgery
- Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
- Clinically significant abnormal laboratory values during 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 |
|---|---|---|
| JP-1366JP-1366, QD | Drug | Group 1, Group 2, Group 3 |
| JP-1366 placeboJP-1366 placebo, QD | Drug | Goup 4, Group 1, Group 2, Group 3 |
| Esomeprazole 40mgEsomeprazole 40mg, QD | Drug | Goup 4 |
| Esomeprazole placeboEsomeprazole placebo, QD | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)
Time frame: 8 weeks
* Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy
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 13 Jul 2022.
- Individual participant dataSharing planned: No
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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 2 study testing JP-1366 and Esomeprazole 40mg in people with GERD, run by Onconic Therapeutics Inc. 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: finished, as of the sponsor's last update on 13 Jul 2022. 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 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?
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?
Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%) (time frame: 8 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 13 Jul 2022.