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Duodenal UlcerPhase 3NCT05010954

Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer

A Phase 3 study testing LXI-15028 50mg group and Lansoprazole 30mg group in people with Duodenal Ulcer, run by Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. at 1 site 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

This is a multi-center, randomized, double-blind, double-dummy, parallel-group, active-controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50mg comparing with Lansoprazole 30 mg after the treatment of duodenal ulcer in Chinese patients for up to 6 weeks. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Duodenal Ulcer
What is being tested?
LXI-15028 50mg group and Lansoprazole 30mg group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
18 Oct 2021to 28 Sep 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject who volunteers to sign the written informed consent form approved by the Ethics Committee and agrees to participate in this study prior to the initiation of any study procedures.
  • Subject who is able to understand and follow the protocol requirements and agrees to participate in all the study visits.
  • Male or female subjects with age ≥18 years and ≤70 years.
  • Subject who is diagnosed as active DU (at least one ulcer, but not more than two ulcers, with the bigger one 0.3-2.0 cm in diameter) by upper gastrointestinal tract endoscopy in the same study institution within 14 days prior to the first dose of investigational drug and is staged as A1 or A2 by using the staging system of Sakita-Miwa.
  • Subject who agrees to use appropriate medical method for contraception during the course of the study (not including women in medically sterile state)

Who cannot join

  • Subject who had participated in any other clinical study of LXI-15028 previously, or had been treated with any P-CAB drug before.
  • Participation in other clinical study within 4 weeks prior to the first dose of study drug, 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 in that study, but withdrew from that study prior to the start of any treatment.
  • Subject who participates in the planning or conduct of this study.
  • Pregnant or lactating women.
Show all 33Show fewer
  • Subject who is known to be allergic to the active ingredient or excipient of the investigational drug (including Lansoprazole).
  • Subject who is unable to undertake an upper gastrointestinal tract endoscopy.
  • Subject who is unable to complete the subject diary by his/her own.
  • Subject who has history of manic-depression, somatoform disorder, personality disorder, schizophrenia or other severe mental disorder.
  • Ulcers caused by endoscopic procedures, e.g. post endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) ulcers.
  • Zollinger-Ellison syndrome.
  • History of malignant tumor within 5 years prior to screening (if the subject's basal cell carcinoma or cervical carcinoma in situ has been cured, he/she will be allowed to participate in this study).
  • Subject with history of upper GI surgery (except endoscopic surgery such as resection of benign polyp, etc.).
  • Subject who plans to be hospitalized for receiving selective surgery during the study.
  • Subject with uncontrolled and unstable hepatic, renal, cardiovascular, respiratory, endocrine, hematologic or central nervous system disease as judged by investigators.
  • Subject with history of chronic alcohol consumption [more than 14 units per week, each unit corresponds to 360 mL beer (ABV ≈ 5%) or 45 mL spirit (ABV ≈ 40%) or 150 mL wine (ABV ≈ 12%)] or drug abuse within 5 years prior to screening.
  • Subject whose upper gastrointestinal tract endoscopy shows GI bleeding (grade I, IIa or IIb per Forrest classification), esophageal stenosis, ulcerative stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus >3 cm (i.e., long-segment Barrett's esophagus, LSBE), gastroesophageal reflux disease, acute gastroduodenal mucosal lesion (AGDML), active gastric ulcer, refractory ulcer, ulcer perforation or suspected malignant disease.
  • Subject who has other severe GI diseases such as Crohn's disease, ulcerative colitis, etc.
  • Use of any PPI, anticholinergic drug, gastrin receptor antagonist, H2 receptor antagonist, prostaglandin, mucosal protective agent, prokinetic, antacid or any other therapeutic drugs for peptic ulcer within 14 days prior to the first dose of study drug.
  • Subject who has thrombotic disease (e.g., cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.) or is currently on anticoagulant therapy.
  • Subject who needs to use nonsteroidal anti-inflammatory drugs (NSAIDs) continuously during the course of the study.
  • Use of any antipsychotic, antidepressant or anti-anxiety agent during screening.
  • Any of the following laboratory abnormalities at screening:
  • AST > Upper limit of normal (ULN);
  • ALT > ULN;
  • Total bilirubin > ULN;
  • Creatinine > 1.5 × ULN;
  • Platelet<lower limit of normal
  • Prothrombin time>1.5 × ULN
  • Subject who has clinically significant abnormality in electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contraction (PVC), Ⅱ or above atrioventricular block, etc.
  • Human immunodeficiency virus (HIV) antibody (+), hepatitis B virus (HBV) surface antigen (+) or hepatitis C virus (HCV) antibody (+) confirmed by tests.
  • Judged by the investigator, there are other conditions compromising the subject's eligibility for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 Compared to Lansoprazole in the Treatment of Duodenal Ulcer in Chinese Patients for up to 6 Weeks

This is a multi-center, randomized, double-blind, double-dummy, parallel-group, active-controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50mg comparing with Lansoprazole 30 mg after the treatment of duodenal ulcer in Chinese patients for up to 6 weeks.

Read the detailed description

Screening-eligible subjects will be randomized into LXI-15028 50 mg group or Lansoprazole 30 mg group at Visit 1 at the ratio of 1:1 and receive study treatment continuously for 4 or 6 weeks.Subjects will take the first dose of the investigational drug on the morning of the randomization day or on the next morning of the randomization day, and start to complete the subject's diary from the day of study treatment initiation(Day 1). After 4 weeks treatment, subjects will return to the study institution for 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 products for another 2 weeks' treatment and then complete Visit 4.All subjects will receive telephone follow-up (Visit 5) on Day 28 ± 3 after the last dose of the investigational products.

Conditions
Duodenal Ulcer
Being tested
LXI-15028 50mg group, Lansoprazole 30mg group
Medical subject headings
Duodenal Ulcer

What participants receive

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

  • LXI-15028 50mg groupDrug

    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 + Lansoprazole 30mg 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 6 weeks

  • Lansoprazole 30mg groupDrug

    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 + Lansoprazole 30mg 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 6 weeks.

Study groups in NCT05010954
Study groupRoleWhat they receive
LXI-15028 50mg group(n=200)ExperimentalNot described
Receives: Drug: LXI-15028 50mg group
Lansoprazole 30mg group (n=200)Active comparatorNot described
Receives: Drug: Lansoprazole 30mg group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative endoscopic healing rate

    Measured: 4 or 6 weeks after receiving oral doses

Secondary outcomes (2)

  1. Endoscopic healing rate at Week 4

    Measured: 4 week after receiving oral doses

  2. Symptom assessment based on subject diary

    Measured: 4 or 6 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.

  1. First posted18 Aug 2021
  2. Study start18 Oct 2021
  3. Primary completion28 Sep 2022
  4. Study completion28 Sep 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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010954
Sponsor's protocol ID
NC821604
Status last verified
Apr 2023
First submitted
11 Aug 2021
Last updated
25 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zong Y, Lan C, Li X, Chen W, Chen H, Liao A, Liu S, Hu C, Wu Y, Zhang S. Efficacy and safety of tegoprazan for duodenal ulcers in Chinese patients: a multicenter, randomized, double-blind, non-inferiority, phase III study. Curr Med Res Opin. 2024 Nov;40(11):1855-1862. doi: 10.1080/03007995.2024.2414090. Epub 2024 Oct 21.

    PubMed 39378042

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LXI-15028 50mg group and Lansoprazole 30mg group in people with Duodenal Ulcer, 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 5 inclusion and 33 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 25 Apr 2023. 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 6 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 NCT05010954, 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 25 Apr 2023.

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