NCT05010954

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	LXI-15028 50mg group	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
DRUG	Lansoprazole 30mg group	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.

Timeline

• Start date: 2021-10-18
• Primary completion: 2022-09-28
• Completion: 2022-09-28
• First posted: 2021-08-18
• Last updated: 2023-04-25

Locations

1 site across 1 country: China