Reflux EsophagitisPhase 2NCT04531475
Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis
A Phase 2 study testing X842 and Lansoprazole in people with Reflux Esophagitis, run by Jiangsu Sinorda Biomedicine Co., Ltd at 16 sites in China.
Trial summary
The purpose of the study is to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Reflux Esophagitis
- What is being tested?
- X842 and Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 16 sitesChina
- Study dates
- 21 Jan 2020to 12 Jan 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18 years ≤ age ≤ 75 years;
- Within 14 days prior to randomization, the subjects are endoscopically diagnosed with reflux esophagitis from Los Angeles (LA) grade A to D (notes: the percent of the subjects with LA grade A of RE should be no more than 60% of the all subjects who are planned to be enrolled in the study);
- Subjects fully understand the trial contents, participate in the trial voluntarily, and sign the informed consent forms.
Who cannot join
- Subjects who receive X842 capsules or other P-CAB drugs in previous clinical studies;
- Subjects known to be allergic to X842 capsules or lansoprazole enteric-coated capsules, or relevant excipients of X842 capsules or lansoprazole enteric-coated capsules, such as lactose, microcrystalline cellulose, croscarmellose sodium, sodium dodecyl sulfate, sodium stearyl fumarate, and silicon dioxide;
- Subjects unable to receive upper gastrointestinal endoscopy;
- Subjects unable to independently complete the subject diary cards;
- Subjects known to have any concomitant disease that may affect the esophagus (eosinophilic esophagitis, esophageal varices, dermatosclerosis, viral or fungal infectious esophagitis, or esophageal stenosis), or have a history of esophageal radiotherapy or cryotherapy (but subjects are eligible for this study if they have concomitant esophageal hiatal hernia)
- Subjects known to have a history of Barrett's esophagus, or who have Barrett's esophagus discovered during endoscopy at screening;
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- Subjects who have acute upper gastrointestinal hemorrhage within 4 weeks prior to enrollment;
- Subjects with active peptic ulcer discovered during upper gastrointestinal endoscopy, or subjects with suspicious or definite malignancies;
- Subjects known to have Zollinger-Ellison syndrome or inflammatory bowel disease (IBD);
- Subjects with concomitant cholecystolithiasis, gallbladder wall crystal or gallbladder polyp discovered by B ultrasonography at screening;
- Subjects with a history of surgery that may affect the esophagus (for example, fundoplication and mechanical distension for esophageal stenosis), or subjects with a history of cholecystectmy or surgery of stomach or duodenum (except endoscopic excision of benign polyps, and except simple suture surgeries such as for gastric perforation);
- Subjects with a history of malignancies within 5 years prior to screening (a subject can participate in the study if his /her skin basal cell carcinoma or carcinoma in situ of uterine cervix has been cured);
- Subjects with concomitant serious diseases of central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system, or hematological system, and the investigator thinks these diseases may mix the study results up or affect the safety of the subject;
- Laboratory test results at screening showing that ALT or AST is larger than 1.5 times of the upper limit of normal, or kidney function index Cr is larger than the upper limit of normal (a re-examination is permitted in the study, and subjects will be excluded if they still fail to meet the inclusion criteria);
- Subjects who use proton pump inhibitors (PPIs), P-CABs, histamine2 receptor antagonists (H2RAs), or gastric mucosal protectors (except hydrotalcite) within 2 weeks prior to randomization;
- Subjects who chronically use (>12 doses / month) non-steroidal anti-inflammatory drug (including cyclooxygenase-2 inhibitor), anti-platelet drug (such as aspirin and clopidogrel), or anticoagulant (such as Warfarin) prior to randomization, and can not stop the medication during the trial;
- At screening, subjects with clinically significant ECG abnormalities, including serious arrhythmia, multifocal preventricular contraction (PVC), grade II or above atrioventricular block, and prolongation of the Q-T interval (QTc≥450 ms in males and QTc≥470 ms in females);
- Diabetic subjects with poorly controlled blood glucose level (fasting blood glucose (FBG) > 10.0 mmol/L), or hypertensive subjects with poorly controlled blood pressure (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg);
- Subjects with known acquired immunodeficiency syndrome (AIDS);
- Subjects who are using atazanavir sulfate or ripivirin hydrochloride at screening;
- Subjects with a history of long-term abuse of drug or alcohol within 6 months prior to screening;
- Female subjects with suspicious or known pregnancy, those in breast-feeding period, or those who are planned to become pregnant during the trial. At the investigator's discretion, women of childbearing age who cannot use a medically-proven and reliable method of contraception from signing the informed consent forms to 4 weeks after the last dose of the study;
- Subject who plan to have a surgery requiring hospitalization, or subject who need to have a surgery during his/her participation in the study;
- Subjects who participate in other drug/medical device clinical studies and use the drug/medical device within 3 months prior to randomization;
- Subjects who are considered unsuitable for participating in this trial by investigators.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Luhe Hospital Capital Medical University
Beijing, 101100
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Binzhou Medical University Hospital
Binzhou, Shandong, 256600
Xiangya Hospital Central South University
Changsha, Hunan, 410008
The First people's Hospital of Changzhou
Changzhou, Jiangsu, 213003
Affiliated Hospital of Xiangnan University
Chenzhou, Hunan, 423000
The Second Affiliated Hospital of Chongqi Medical University
Chongqing, Sichuan, 400010
The Affiliated Hospital of Guzihou Medical University
Guiyang, Guizhou, 550004
Jinan Central Hospital
Jinan, Shandong, 250013
Liuan People's Hospital
Liu‘an, Anhui, 237016
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Jiangxi PingXiang People's Hospital
Pingxiang, Jiangxi, 337000
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 250065
Taizhou Municipal Hospital
Taizhou, Zhejiang, 318000
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
About this study
Official title: A Multicenter, Randomized, Double-blind, Double-simulation, Active Comparator-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules at Different Dosages in Patients With Reflux Esophagitis
The purpose of the study is to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.
Read the detailed description
It is designed as a multicenter, randomized, double-blind, double-simulation, high and low dose group, active comparator-controlled, parallel-group study to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.
- Conditions
- Reflux Esophagitis
- Being tested
- X842, X842 Placebo, Lansoprazole, Lansoprazole Placebo
- Keywords
- X842, Reflux Esophagitis, GERD, PCAB
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X842Drug
Also called Undecided
X842 capsules
X842 PlaceboDrug
Also called Undecided
X842 placebo-matching capsules
LansoprazoleDrug
Also called Undecided
Lansoprazole capsules
Lansoprazole PlaceboDrug
Also called Undecided
Lansoprazole placebo-matching capsules
| Study group | Role | What they receive |
|---|---|---|
| X842 50 mg QD | Experimental | X842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks. Receives: Drug: X842; Drug: Lansoprazole Placebo |
| X842 100 mg QD | Experimental | X842 100 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks. Receives: Drug: X842; Drug: Lansoprazole Placebo |
| Lansoprazole 30 mg QD | Experimental | Lansoprazole 30 mg, capsule, orally, once daily and X842 placebo-matching capsule, orally, once daily up to 4 weeks. Receives: Drug: X842 Placebo; Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4 of Treatment
Subjects cured of RE are defined as subjects who are endoscopically confirmed to be cured of RE.
Measured: 4 weeks
Secondary outcomes (11)
Proportion of Subjects Whose Reflux Esophagitis LA Grade is Decreased by ≥1 as Confirmed by Endoscopy at Week 4 of Treatment
The endoscopic results must describe RE severity according to the LA grading criteria.
Measured: 4 weeks
Changes in Gerd-Q Score at Week 2 and 4 Compared With the Baseline
Subjects must record RE symptoms that occur within 7d prior to each visit in the Gerd-Q under the guidance of the investigator.
Measured: Week 2 and Week 4
Changes in Serum Gastrin at Week 2 and 4 of Treatment Compared with the Baseline
Serum gastrin testing will be conducted at the central laboratory. The change between the serum gastrin values collected at Weeks 2 and 4 relative to baseline.
Measured: Week 2 and Week 4
Measurement of the PK Profile
Plasma concentrations of X842 and its metabolites are measured to determine X842 exposure in patients.
Measured: Week 2 and Week 4
Number of Subjects Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
Adverse event is defined as any adverse medical event that is observed in a subject who is receiving a drug treatment or in a clinical study, and that does not necessarily have a causal relationship with the treatment.
Measured: Up to 6 weeks
Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood serum
Number of subjects with any markedly abnormal values in laboratory tests of blood serum collected throughout study is reported.
Measured: Up to 6 weeks
Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood
Number of subjects with any markedly abnormal values in laboratory tests of blood collected throughout study is reported.
Measured: Up to 6 weeks
Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of urine
Number of subjects with any markedly abnormal values in laboratory tests of urine collected throughout study is reported.collected throughout study is reported.
Measured: Up to 6 weeks
Number of Subjects With Markedly Abnormal Electrocardiogram (ECG) Findings
The investigator or the sub-investigator interpreted the ECG using one of the following categories: "within normal limits", "abnormal but not clinically significant", or "abnormal and clinically significant".
Measured: Up to 6 weeks
Vital signs of body temperature
°C = degrees Celsius
Measured: Up to 6 weeks
Vital signs of blood pressure
Blood pressure measurements included systolic (mmHg) and diastolic (mmHg).
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start21 Jan 2020
- Primary completion24 Oct 2020
- Study completion12 Jan 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 Reflux EsophagitisStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After completing the relevant laboratory tests and endoscopic examinations at screening, subjects who meet the inclusion criteria and do not meet the exclusion criteria are randomly assigned to X842 capsule low-dose group, X842 capsule high-dose group, and lansoprazole enteric-coated capsule group for 4-week treatment and then receive endoscopy. In the study, the duration of subjects receiving treatment with the test drug or comparator is 4 weeks. If a subject has the reflux esophagitis (RE) uncured under endoscopy at week 4 of treatment, the sponsor will give the subject lansoprazole enteric-coated capsules for free for another 4 weeks' treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Sinorda Biomedicine Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pingsheng Hu, Ph.D, Study chair, Jiangsu Sinorda Biomedicine Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531475
- Sponsor's protocol ID
- SND-X842-201
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2020
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu S, Han M, Zong Y, Meng F, Liu Q, Tuo B, Zhang Z, Wang Q, Liu X, He S, Zhen Y, Shao D, Wang S, Xu B, Li X, Tang H, Miu Y, Liu C, Hu J, Hu P, Xiu J, Lu M, Wu Y, Zhang S. A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (X842) and Lansoprazole for the Treatment of Patients With Erosive Esophagitis. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00803. doi: 10.14309/ctg.0000000000000803.
PubMed 39836012
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double-simulation, Active Comparator-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules at Different Dosages in Patients With Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT04531475
- Acronym / sponsor ID
- SND-X842-201
- Conditions
- Reflux Esophagitis
- Keywords
- X842, Reflux Esophagitis, GERD, PCAB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Jiangsu Sinorda Biomedicine Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 28 Aug 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 the study is to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.
Detailed description
It is designed as a multicenter, randomized, double-blind, double-simulation, high and low dose group, active comparator-controlled, parallel-group study to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- After completing the relevant laboratory tests and endoscopic examinations at screening, subjects who meet the inclusion criteria and do not meet the exclusion criteria are randomly assigned to X842 capsule low-dose group, X842 capsule high-dose group, and lansoprazole enteric-coated capsule group for 4-week treatment and then receive endoscopy. In the study, the duration of subjects receiving treatment with the test drug or comparator is 4 weeks. If a subject has the reflux esophagitis (RE) uncured under endoscopy at week 4 of treatment, the sponsor will give the subject lansoprazole enteric-coated capsules for free for another 4 weeks' treatment.
| Arm | Type | Receives |
|---|---|---|
| X842 50 mg QD | Experimental | Drug: X842, Drug: Lansoprazole PlaceboX842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks. |
| X842 100 mg QD | Experimental | Drug: X842, Drug: Lansoprazole PlaceboX842 100 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks. |
| Lansoprazole 30 mg QD | Experimental | Drug: X842 Placebo, Drug: LansoprazoleLansoprazole 30 mg, capsule, orally, once daily and X842 placebo-matching capsule, orally, once daily up to 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, 18 years ≤ age ≤ 75 years;
- Within 14 days prior to randomization, the subjects are endoscopically diagnosed with reflux esophagitis from Los Angeles (LA) grade A to D (notes: the percent of the subjects with LA grade A of RE should be no more than 60% of the all subjects who are planned to be enrolled in the study);
- Subjects fully understand the trial contents, participate in the trial voluntarily, and sign the informed consent forms.
Key exclusion criteria (25 listed)
- Subjects who receive X842 capsules or other P-CAB drugs in previous clinical studies;
- Subjects known to be allergic to X842 capsules or lansoprazole enteric-coated capsules, or relevant excipients of X842 capsules or lansoprazole enteric-coated capsules, such as lactose, microcrystalline cellulose, croscarmellose sodium, sodium dodecyl sulfate, sodium stearyl fumarate, and silicon dioxide;
- Subjects unable to receive upper gastrointestinal endoscopy;
- Subjects unable to independently complete the subject diary cards;
- Subjects known to have any concomitant disease that may affect the esophagus (eosinophilic esophagitis, esophageal varices, dermatosclerosis, viral or fungal infectious esophagitis, or esophageal stenosis), or have a history of esophageal radiotherapy or cryotherapy (but subjects are eligible for this study if they have concomitant esophageal hiatal hernia)
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 |
|---|---|---|
| X842Also: UndecidedX842 capsules | Drug | X842 100 mg QD, X842 50 mg QD |
| X842 PlaceboAlso: UndecidedX842 placebo-matching capsules | Drug | Lansoprazole 30 mg QD |
| LansoprazoleAlso: UndecidedLansoprazole capsules | Drug | Lansoprazole 30 mg QD |
| Lansoprazole PlaceboAlso: UndecidedLansoprazole placebo-matching capsules | Drug | X842 100 mg QD, X842 50 mg QD |
Primary outcome
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4 of Treatment
Time frame: 4 weeks
Subjects cured of RE are defined as subjects who are endoscopically confirmed to be cured of RE.
11 secondary outcomes
Proportion of Subjects Whose Reflux Esophagitis LA Grade is Decreased by ≥1 as Confirmed by Endoscopy at Week 4 of Treatment
Time frame: 4 weeks
Changes in Gerd-Q Score at Week 2 and 4 Compared With the Baseline
Time frame: Week 2 and Week 4
Changes in Serum Gastrin at Week 2 and 4 of Treatment Compared with the Baseline
Time frame: Week 2 and Week 4
Measurement of the PK Profile
Time frame: Week 2 and Week 4
Number of Subjects Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
Time frame: Up to 6 weeks
Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood serum
Time frame: Up to 6 weeks
Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood
Time frame: Up to 6 weeks
Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of urine
Time frame: Up to 6 weeks
Number of Subjects With Markedly Abnormal Electrocardiogram (ECG) Findings
Time frame: Up to 6 weeks
Vital signs of body temperature
Time frame: Up to 6 weeks
Vital signs of blood pressure
Time frame: Up to 6 weeks
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 17 Jul 2025.
- Derived from this study: PubMed 39836012Zhu S, Han M, Zong Y, Meng F, Liu Q, Tuo B, Zhang Z, Wang Q, Liu X, He S, Zhen Y, Shao D, Wang S, Xu B, Li X, Tang H, Miu Y, Liu C, Hu J, Hu P, Xiu J, Lu M, Wu Y, Zhang S. A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (X842) and Lansoprazole for the Treatment of Patients With Erosive Esophagitis. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00803. doi: 10.14309/ctg.0000000000000803.
- 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.
Pingsheng Hu, Ph.D study chair
Jiangsu Sinorda Biomedicine Co., Ltd
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing X842 and Lansoprazole in people with Reflux Esophagitis, run by Jiangsu Sinorda Biomedicine Co., Ltd at 16 sites 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 3 inclusion and 25 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 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?
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4 of Treatment (time frame: 4 weeks). 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 NCT04531475, 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 17 Jul 2025.