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Reflux EsophagitisPhase 3X842NCT07079540

The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis

A Phase 3 study testing X842 and Lansoprazole in people with Reflux Esophagitis, run by Jiangsu Sinorda Biomedicine Co., Ltd at 53 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy and safety of X842 Capsules 50 mg compared to Lansoprazole Enteric Capsules for the treatment of reflux esophagitis, and to characterize the population pharmacokinetics of X842 capsules in this patient population. 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
380 participants
Where
53 sitesChina
Study dates
24 Jun 2021to 1 Dec 2022
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 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 7 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 20% of the all subjects who are planned to be enrolled in the study);
  • Subjects who can independently complete the subject diary cards;
  • 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;
  • Endoscopic examination revealed concomitant diseases potentially affecting the esophagus, excluding hiatal hernia, and excluding Barrett's esophagus with metaplastic columnar epithelium that either does not involve the entire esophageal circumference or is short-segment (< 3 cm in length).
  • Patients with rheumatic/autoimmune diseases potentially affecting esophageal motility (e.g., scleroderma, undifferentiated connective tissue disease), or those with a history of esophageal radiotherapy or cryotherapy;
  • Subjects who have acute upper gastrointestinal hemorrhage within 4 weeks prior to enrollment;
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  • 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 history of surgery affecting the structure or function of the esophagus, stomach, or duodenum, or surgery altering gastric acid secretion.
  • Subjects who plan to undergo surgical procedures during the study period that may alter gastric acid secretion (e.g., abdominal surgery, vagotomy, or craniectomy).
  • 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 of therapeutic doses of GERD medications within 7 days prior to randomization, eg. proton pump inhibitors (PPIs), P-CABs, histamine2 receptor antagonists (H2RAs), or gastric mucosal protectors (except hydrotalcite), prokinetic drugs, and traditional Chinese medicines;
  • Subjects who chronically use 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 ventricular premature complexes, grade II or above atrioventricular block, and prolongation of the Q-Tc interval (QTc≥450 ms in males and QTc≥470 ms in females);
  • 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 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;
  • 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

53 sites in 1 country.

53 sites in 1 country

China53 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100091

  • Beijing Luhe Hospital Capital Medical University

    Beijing, 101100

  • Affiliated Hospital of Binzhou Medical University

    Binzhou, Shandong, 256600

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 061000

  • The Second Hospital of Jilin University

    Changchun, Jinlin, 130022

  • The First Hospital of Jilin University

    Changchun, Jinlin, 130031

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • The First People's Hospital of Chenzhou City

    Chenzhou, Hunan, 423000

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • Chongqing University Three Gorges Hospital

    Chongqing, 404000

  • The 900th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

    Fuzhou, Fujian, 350001

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • The Affiliated Hospital of Guzihou Medical University

    Guiyang, Guizhou, 550004

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The Second Affiliated Hospital of South China University

    Hengyang, Hunan, 421001

  • The First Affiliated Hospital Of University Of South China

    Hengyang, Hunan

  • Huai 'an First People's Hospital

    Huaian, Jiangsu, 223300

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516000

  • Jinan Central Hospital

    Ji'nan, Shandong, 250013

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222061

  • Liuan People's Hospital

    Liu‘an, Anhui, 237016

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi, 545005

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Nanning People's Hospital

    Nanjing, Guangxi, 530031

  • Zhongda Hospital of Southeast University

    Nanjing, Jiangsu, 210000

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337099

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Tongji Hospital Affiliated to Tongji University

    Shanghai, 200065

  • Shanghai East Hospital

    Shanghai, 200120

  • Shengjing Hospital Of China Medical University

    Shenyang, Liaoning, 110134

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • Taihe Hospital of Shiyan City

    Shiyan, Hubei, 442700

  • Nankai Hospital of Tianjin City

    Tianjin, 300100

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325027

  • Affiliated Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430022

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • Xuancheng People's Hospital

    Xuancheng, Anhui, 242000

  • Affiliated Hospital of Yangzhou University(Yangzhou First People's Hospital)

    Yangzhou, Jiangsu, 225003

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Zhengzhou People's Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212013

  • Zigong Fourth People's Hospital

    Zigong, Sichuan, 643000

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Phase III Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules in Patients With Reflux Esophagitis

To evaluate the efficacy and safety of X842 Capsules 50 mg compared to Lansoprazole Enteric Capsules for the treatment of reflux esophagitis, and to characterize the population pharmacokinetics of X842 capsules in this patient population.

Read the detailed description

This study uses a multicenter, randomized, double-blind, double-dummy, active-controlled parallel-group, non-inferiority design to compare the efficacy and safety of X842 capsules (50 mg) in the treatment of reflux esophagitis over 4 to 8 weeks in comparison with lansoprazole enteric-coated capsules(30 mg) . Additionally, the population pharmacokinetics characteristics of X842 capsules in patients with reflux esophagitis is observed.

Being tested
X842, X842 Placebo, Lansoprazole, Lansoprazole Placebo
Keywords
Reflux Esophagitis, X842, Population Pharmacokinetics, PopPK, Lansoprazole
Medical subject headings
Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • X842Drug

    Also called X842 capsules

    X842 capsules

  • X842 PlaceboDrug

    X842 placebo-matching capsules

  • LansoprazoleDrug

    Also called Lansoprazole capsules

    Lansoprazole capsules

  • Lansoprazole PlaceboDrug

    Lansoprazole placebo-matching capsules

Study groups in NCT07079540
Study groupRoleWhat they receive
X842 50mg QDExperimentalX842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 to 8 weeks.
Receives: Drug: X842; Drug: Lansoprazole Placebo
lansoprazole 30mg QDActive comparatorLansoprazole 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.

  1. Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 8

    Healing of reflux esophagitis is defined as endoscopic confirmation of resolved esophagitis (absence of esophageal mucosal breaks) in subjects.

    Measured: 8 weeks

Secondary outcomes (12)

  1. Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4

    Healing of reflux esophagitis is defined as endoscopic confirmation of resolved esophagitis (absence of esophageal mucosal breaks) in subjects.

    Measured: 4 weeks

  2. Improvement rate in the frequency and severity of individual clinical symptoms (heartburn, regurgitation) of reflux esophagitis at Weeks 2, 4, and 8 after treatment initiation.

    Improvement in the frequency of clinical symptom occurrence: Defined as subjects whose symptom frequency score before treatment was ≥1 point had a reduction of ≥1 point after treatment compared to before treatment.

    Improvement in the severity of clinical symptoms: Defined as a reduction of ≥1 point in the symptom severity score of subjects with a score of ≥1 point before treatment after treatment compared to before treatment.

    Measured: 2,4,8 weeks

  3. Response rates for individual symptom domains (heartburn, regurgitation) in reflux esophagitis at Weeks 2, 4, and 8 post-baseline.

    Resolution of individual clinical symptoms: defined as the achievement of score 0 in both severity and frequency for symptoms with baseline scores ≥1.

    Measured: 2.4.8 weeks

  4. Overall symptomatic resolution rate for reflux esophagitis at Weeks 2, 4, and 8

    Overall Clinical Symptom Resolution: Defined as the achievement of a score of 0 (i.e., complete disappearance) for all symptoms of reflux esophagitis in subjects with any individual symptom score ≥1 at baseline.

    Measured: 2,4,8 weeks

  5. Change in serum gastrin levels from baseline at Weeks 4 and 8 of treatment

    Serum gastrin testing will be conducted at the central laboratory. The change between the serum gastrin values collected at Weeks 4 and 8 relative to baseline.

    Measured: 4, 8 weeks

  6. 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 8 weeks

  7. Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood serum 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 8 weeks

  8. 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 8 weeks

  9. 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 8 weeks

  10. 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 8 weeks

  11. Vital signs

    Blood pressure, respiration, heart rate and body temperature were evaluated at each visit during the screening period and the double-blind treatment period

    Measured: up to 8 weeks

  12. Pharmacokinetic evaluation

    Quantification of plasma concentrations of X842 and its metabolites to characterize the population pharmacokinetic profile of X842 capsules in GERD patients.

    Measured: up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start24 Jun 2021
  3. Primary completion27 Jul 2022
  4. Study completion1 Dec 2022

Resources

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
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 under blinding at a 3:1 ratio assigned to test group(X842 Capsule)and control group ( Lansoprazole enteric-coated Capsules) for for 4-week treatment and then receive endoscopy. If endoscopy shows healed esophagitis, treatment will be discontinued; if esophagitis remains unhealed, treatment continues for an additional 4 weeks. The minimum treatment duration with either test or control drug is 4 weeks, and the maximum is 8 weeks in this study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079540
Sponsor's protocol ID
SND-X842-301
Other IDs
ChiCTR20210736
Acronym
X842
Status last verified
Jul 2025
First submitted
14 Jul 2025
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing X842 and Lansoprazole in people with Reflux Esophagitis, run by Jiangsu Sinorda Biomedicine Co., Ltd at 53 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 4 inclusion and 21 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 23 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 53 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 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?

Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 8 (time frame: 8 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 NCT07079540.

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 23 Jul 2025.

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