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Efficacy and Safety of LXI-15028 Comparing With Esomeprazole in the Treatment of Erosive Esophagitis

NCT03615677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2020-04-15

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, parallel-group, active controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg comparing with esomeprazole 40 mg after the treatment of erosive esophagitis in Chinese patients for up to 8 weeks.

Screening-eligible subjects will be randomized into LXI-15028 50mg treatment group or esomeprazole 40mg treatment group at Visit 2 (Day 0) stratified by LA grade (A or B/C/D) at baseline according to the ratio of 1:1 and receive study treatment continuously for 4 or 8 weeks. They will start to take the investigational products from the following morning (Day 1) of Visit 2, and start to complete the subject's diary from the day of study treatment initiation. After 4 weeks of study treatment (treatment period 1), subjects will return to the study site and complete 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 product after completing the fasting examinations at Visit 3, and continue another 4 weeks of study treatment (treatment period 2) and complete Visit 4. All the subjects will be followed up by phone (Visit 5) at Day 28±3 after the last dose of investigational products.

Conditions

  • Erosive Esophagitis (EE)

Interventions

DRUG

LXI-15028 50mg

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 + Esomeprazole 40mg 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 8 weeks.

DRUG

Esomeprazole 40mg

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 + Esomeprazole 40mg 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 8 weeks.

Sponsors & Collaborators

  • Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhaoshen Li, Doctor · Changhai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2019-10-18
Completion
2019-10-18

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03615677 on ClinicalTrials.gov