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

NCT05010954 | Completed Phase 3

• 1 other identifier: NC821604
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Duodenal Ulcer

Outcome Measures

Primary Outcomes (1)

• Cumulative endoscopic healing rate

  4 or 6 weeks after receiving oral doses

Secondary Outcomes (2)

• Endoscopic healing rate at Week 4

  4 week after receiving oral doses

• Symptom assessment based on subject diary

  4 or 6 weeks after receiving oral doses

Study Arms (2)

LXI-15028 50mg group(n=200)

EXPERIMENTAL

Drug: LXI-15028 50mg group

Lansoprazole 30mg group (n=200)

ACTIVE COMPARATOR

Drug: Lansoprazole 30mg group

Interventions

LXI-15028 50mg group DRUG

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

LXI-15028 50mg group(n=200)

Lansoprazole 30mg group DRUG

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.

Lansoprazole 30mg group (n=200)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• 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.

  PMID: 39378042 DERIVED

MeSH Terms

Conditions

Duodenal Ulcer

Interventions

Population Groups; Lansoprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: October 18, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)