Erosive Esophagitis (EE)Phase 3NCT03615677
Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis
A Phase 3 study testing LXI-15028 50mg and Esomeprazole 40mg in people with Erosive Esophagitis (EE), run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.
Trial summary
This is a multi-center, randomized, double-blind, parallel-group, active controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg comparing with esomeprazole 40 mg after the treatment of erosive esophagitis in Chinese patients for up to 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Esophagitis (EE)
- What is being tested?
- LXI-15028 50mg and Esomeprazole 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2018to 18 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Subject who volunteers to sign the written informed consent form approved by the independent ethics committee and agrees to participate in this study prior to the initiation of any study procedures.
- 2) Subject who is able to understand and comply with the protocol requirements and agrees to participate in all the study visits.
- 3) Male or female subjects with age ≥ 18 years. 4) Having experienced heartburn and regurgitation within 7 days prior to screening, with the frequency and severity in symptom assessment meeting at least one of the following items:
- Mild heartburn for at least 2 days, with regurgitation;
- Mild regurgitation for at least 2 days, with heartburn;
- Moderate or more severe heartburn for at least 1 day, with regurgitation;
- Moderate or more severe regurgitation for at least 1 day, with heartburn. (Note: To be determined by using the RDQ [item a, b, e, f] completed by subject.) 5) Subject who is diagnosed as Los Angeles (LA) grade A to D erosive esophagitis through upper gastrointestinal endoscopy within 14 days prior to the initiation of study treatment. (Note: The target of enrollment is to ensure the number of subjects with LA grade A does not exceed 60% of the total number of subject enrolled)
Who cannot join
- 1) Subject who had participated in this study previously, or had participated in other P-CAB drug clinical studies.
- 2) Participation in other clinical study within 3 months prior to screening, except for the two following circumstances:
- The study which the subject is participating or participated in is a non-interventional study (e.g. observational study or questionnaire survey) and is judged by investigators to have no interference with the efficacy and safety evaluation in the present study;
- Subject had signed the informed consent form and participated in another study (NC821603) sponsored by this sponsor in the same study site, but had been withdrawn from that study prior to the start of any treatment.
- 3) Subjects who participate in the plan or conduction of this study (e.g., staff of the sponsor or study site).
- 4) Subject who is known to be allergic to the active ingredient or excipient of the investigational product (including esomeprazole).
Show all 27Show fewer
- 5) Subject who is unable to undertake an upper gastrointestinal endoscopy. 6) Subject who is unable to complete the subject's diary by oneself. 7) Subject who has history of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder or other mental disorder.
- 8) Subject who has symptoms such as odynophagia, serious dysphagia, bleeding, decreased body weight, anemia or hematochezia that represent "warning" to presume gastrointestinal malignant disease, unless the possibility of the malignant disease is excluded through an endoscopy.
- 9) Subject who is diagnosed as achalasia of the cardia, secondary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), Zollinger-Ellison syndrome or eosinophilic esophagitis.
- 10) Subject with history of digestive tract surgery, except for simple fenestration, appendectomy, cholecystectomy or endoscopic resection of benign tumor. 11) Subject who plans to be hospitalized for receiving selective surgery during the study.
- 12) Subject with non-reflux-related esophageal stenosis, hiatus hernia, gastroesophageal varices, active peptic ulcer, gastric bleeding or malignant tumor that is found in upper gastrointestinal endoscopy.
- 13) Subject with uncontrolled and unstable hepatic, renal, cardiovascular, respiratory, endocrine or central nervous system disease as judged by investigators.
- 14) Subject with history of chronic alcohol consumption (more than 14 cups per week, each cup corresponds to 360 mL beer or 150 mL wine or 45 mL liquor) or drug abuse within 5 years prior to screening.
- 15) Use of any PPI, P-CAB or other drugs related to the treatment of GERD (including H2-receptor antagonist, prostaglandin or mucosal protective agent), or any other antiemetic, emetic drugs within two weeks prior to the initiation of study treatment.
- 16) Subject who needs non-steroidal anti-inflammatory drugs (NSAIDs) during the study, unless the subject had started to use low dose aspirin (≤ 100 mg/day) prior to screening.
- 17) Use of potent-to-moderate cytochrome metabolism enzyme CYP3A4 inhibitor or inducer within 4 weeks prior to study treatment, including but not limited to the following drugs:
- CYP3A4 inhibitors: Ketoconazole, Indinavir, Saquinovir, Atazanavir, Amprenavir, Fosamprenavir, Nefazodone, Itraconazole, Telithromycin, Fluconazole, Troleandomycin, Cimetidine, Aprepitant, Fluvoxamine, Amiodarone, Ritonavir, Erythromycin, Clarithromycin, and Diltiazem;
- CYP3A4 inducers: Barbiturate, Phenytoin, Rifampin, St John's wort, Carbamazepine, Dexamethasone, Rifabutin, and Phenobarbital etc.; 18) Subject currently using antipsychotic drug, antidepressant agent or anti-anxiety agent.
- 19) Any of the following laboratory abnormalities at screening:
- AST ≥ 2 x upper limit of normal (ULN);
- ALT ≥ 2 x ULN;
- ALP ≥ 2 x ULN;
- γ-GT ≥ 2 x ULN;
- Total bilirubin ≥ 2 x ULN;
- BUN (or urea) ≥ 1.5 x ULN;
- Creatinine ≥ 1.5 x ULN 20) Subject with clinically significant abnormality in ECG at screening, including serious arrhythmia, multifocal premature ventricular contraction (PVC), second degree or above atrioventricular block, prolonged QT interval (QTc ≥ 450 ms for male, QTc ≥ 470 ms for female).
- 21) Current infection of human immune deficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) confirmed by tests.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis in Chinese Patients for up to 8 Weeks
This is a multi-center, randomized, double-blind, parallel-group, active controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg comparing with esomeprazole 40 mg after the treatment of erosive esophagitis in Chinese patients for up to 8 weeks.
Screening-eligible subjects will be randomized into LXI-15028 50mg treatment group or esomeprazole 40mg treatment group at Visit 2 (Day 0) stratified by LA grade (A or B/C/D) at baseline according to the ratio of 1:1 and receive study treatment continuously for 4 or 8 weeks. They will start to take the investigational products from the following morning (Day 1) of Visit 2, and start to complete the subject's diary from the day of study treatment initiation. After 4 weeks of study treatment (treatment period 1), subjects will return to the study site and complete Visit 3. For the subjects who achieve endoscopic healing at Visit 3, the study treatment will be terminated. The subjects who fail to achieve endoscopic healing at Visit 3 will receive newly dispensed investigational product after completing the fasting examinations at Visit 3, and continue another 4 weeks of study treatment (treatment period 2) and complete Visit 4. All the subjects will be followed up by phone (Visit 5) at Day 28±3 after the last dose of investigational products.
- Conditions
- Erosive Esophagitis (EE)
- Being tested
- LXI-15028 50mg, Esomeprazole 40mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LXI-15028 50mgDrug
The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products (LXI-15028 50mg active agent + Esomeprazole 40mg matching placebo . If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks.
Esomeprazole 40mgDrug
The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products ( LXI-15028 50mg matching placebo + Esomeprazole 40mg active agent ). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LXI-15028 50mg group (n=130) | Experimental | Not described Receives: Drug: LXI-15028 50mg |
| Esomeprazole 40mg group (n=130) | Active comparator | Not described Receives: Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative endoscopic healing rate
Percentage of patients with healing erosion based on the upper Gastrointestinal (GI) endoscopy following 8 weeks of study treatment
Measured: 4 or 8 weeks after receiving oral doses
Secondary outcomes (5)
Endoscopic healing rate at Week 4
Percentage of patients with healing erosion based on the upper Gastrointestinal (GI) endoscopy following 4 weeks of study treatment
Measured: 4 week after receiving oral doses
Change of Reflux Disease Questionnaire (RDQ) score for main symptoms
Total score for main symptoms (heartburn and regurgitation) (Total score is the sum of the score of heartburn and regurgitation, the range is 0-20, the higher score indicates the worse sympotom)
Measured: 4 or 8 weeks after receiving oral doses
Change of Reflux Disease Questionnaire (RDQ) score for subcategory
Score for each Reflux Disease Questionnaire (RDQ) subcategory (heartburn, regurgitation and dyspepsia) (The range is 0-10 for every subcategory score)
Measured: 4 or 8 weeks after receiving oral doses
Symptom assessment based on subject diary
Percentage of days without main symptoms (heartburn and regurgitation) during 1 week (7 days), 4 weeks and 8 weeks from the initiation of study treatment
Measured: 4 or 8 weeks after receiving oral doses
Change of Gastro Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
Change of Gastro Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score of each post-treatment visit from baseline at each post-treatment visit from baseline
Measured: 4 or 8 weeks after receiving oral doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start24 Oct 2018
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
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 Erosive Esophagitis (EE)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, Doctor, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615677
- Sponsor's protocol ID
- NC821602
- Status last verified
- Apr 2020
- First submitted
- 9 Jul 2018
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu H, Xue Q, Song Y, Zhang Z, Li X, Lyu S, Zhan Q, Liu F, Lu L, Zhong L, Chen W, Shao D, Ding Y, Liu D, Yang X, Huang Z, Li Z, Du Y. Efficacy and safety of tegoprazan (LXI-15028) vs . esomeprazole in patients with erosive esophagitis: A multicenter, randomized, double-blind, non-inferiority phase Ⅲ trial. Chin Med J (Engl). 2025 Oct 5;138(19):2464-2471. doi: 10.1097/CM9.0000000000003276. Epub 2024 Oct 30.
PubMed 39474720
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis in Chinese Patients for up to 8 Weeks
- ClinicalTrials.gov ID
- NCT03615677
- Acronym / sponsor ID
- NC821602
- Conditions
- Erosive Esophagitis (EE)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 6 Aug 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.
This is a multi-center, randomized, double-blind, parallel-group, active controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg comparing with esomeprazole 40 mg after the treatment of erosive esophagitis in Chinese patients for up to 8 weeks.
Screening-eligible subjects will be randomized into LXI-15028 50mg treatment group or esomeprazole 40mg treatment group at Visit 2 (Day 0) stratified by LA grade (A or B/C/D) at baseline according to the ratio of 1:1 and receive study treatment continuously for 4 or 8 weeks. They will start to take the investigational products from the following morning (Day 1) of Visit 2, and start to complete the subject's diary from the day of study treatment initiation. After 4 weeks of study treatment (treatment period 1), subjects will return to the study site and complete Visit 3. For the subjects who achieve endoscopic healing at Visit 3, the study treatment will be terminated. The subjects who fail to achieve endoscopic healing at Visit 3 will receive newly dispensed investigational product after completing the fasting examinations at Visit 3, and continue another 4 weeks of study treatment (treatment period 2) and complete Visit 4. All the subjects will be followed up by phone (Visit 5) at Day 28±3 after the last dose of investigational products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LXI-15028 50mg group (n=130) | Experimental | Drug: LXI-15028 50mg |
| Esomeprazole 40mg group (n=130) | Active comparator | Drug: Esomeprazole 40mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1) Subject who volunteers to sign the written informed consent form approved by the independent ethics committee and agrees to participate in this study prior to the initiation of any study procedures.
- 2) Subject who is able to understand and comply with the protocol requirements and agrees to participate in all the study visits.
- 3) Male or female subjects with age ≥ 18 years. 4) Having experienced heartburn and regurgitation within 7 days prior to screening, with the frequency and severity in symptom assessment meeting at least one of the following items:
- Mild heartburn for at least 2 days, with regurgitation;
- Mild regurgitation for at least 2 days, with heartburn;
Key exclusion criteria (27 listed)
- 1) Subject who had participated in this study previously, or had participated in other P-CAB drug clinical studies.
- 2) Participation in other clinical study within 3 months prior to screening, except for the two following circumstances:
- The study which the subject is participating or participated in is a non-interventional study (e.g. observational study or questionnaire survey) and is judged by investigators to have no interference with the efficacy and safety evaluation in the present study;
- Subject had signed the informed consent form and participated in another study (NC821603) sponsored by this sponsor in the same study site, but had been withdrawn from that study prior to the start of any treatment.
- 3) Subjects who participate in the plan or conduction of this study (e.g., staff of the sponsor or study site).
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 |
|---|---|---|
| LXI-15028 50mgThe investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products (LXI-15028 50mg active agent + Esomeprazole 40mg matching placebo . If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks. | Drug | LXI-15028 50mg group (n=130) |
| Esomeprazole 40mgThe investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products ( LXI-15028 50mg matching placebo + Esomeprazole 40mg active agent ). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks. | Drug | Esomeprazole 40mg group (n=130) |
Primary outcome
Cumulative endoscopic healing rate
Time frame: 4 or 8 weeks after receiving oral doses
Percentage of patients with healing erosion based on the upper Gastrointestinal (GI) endoscopy following 8 weeks of study treatment
5 secondary outcomes
Endoscopic healing rate at Week 4
Time frame: 4 week after receiving oral doses
Change of Reflux Disease Questionnaire (RDQ) score for main symptoms
Time frame: 4 or 8 weeks after receiving oral doses
Change of Reflux Disease Questionnaire (RDQ) score for subcategory
Time frame: 4 or 8 weeks after receiving oral doses
Symptom assessment based on subject diary
Time frame: 4 or 8 weeks after receiving oral doses
Change of Gastro Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score
Time frame: 4 or 8 weeks after receiving oral doses
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 15 Apr 2020.
- Derived from this study: PubMed 39474720Zhu H, Xue Q, Song Y, Zhang Z, Li X, Lyu S, Zhan Q, Liu F, Lu L, Zhong L, Chen W, Shao D, Ding Y, Liu D, Yang X, Huang Z, Li Z, Du Y. Efficacy and safety of tegoprazan (LXI-15028) vs . esomeprazole in patients with erosive esophagitis: A multicenter, randomized, double-blind, non-inferiority phase Ⅲ trial. Chin Med J (Engl). 2025 Oct 5;138(19):2464-2471. doi: 10.1097/CM9.0000000000003276. Epub 2024 Oct 30.
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.
Zhaoshen Li, Doctor principal investigator
Changhai Hospital
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 LXI-15028 50mg and Esomeprazole 40mg in people with Erosive Esophagitis (EE), run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site in China.
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 7 inclusion and 27 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 15 Apr 2020. 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 China. 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 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?
Cumulative endoscopic healing rate (time frame: 4 or 8 weeks after receiving oral doses). 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 NCT03615677, 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 15 Apr 2020.