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A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Phase III Study to Evaluate the Efficacy and Safety of LXI-15028 in Non-erosive Reflux Disease in Chinese Patients for 4 Weeks

NCT03591653 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2020-04-08

No results posted yet for this study

Summary

This is one multi-center, randomized, double-blind, parallel-group, placebo controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028 50 mg in treatment of non-erosive reflux disease in Chinese patients for 4 weeks.

Screening-eligible subjects will be randomized into LXI-15028 50mg group or placebo group at Visit 2 (Day 0) according to the ratio of 1:1 and receive study treatment for 4 weeks. They will start to take the investigational products in the following morning of Visit 2 (Day 1) and start to complete the subject's diary from the day of study treatment initiation. After 2 weeks of study treatment, subjects will return to the study site and complete Visit 3, after which receive study treatment for another 2 weeks and then complete Visit 4. On the day of Visit 4, subjects will not take any drug. All the subjects will be followed up by phone (Visit 5) at Day 28±3 after the last dose of study medication.

Conditions

  • Non-erosive Reflux Disease

Interventions

DRUG

LXI-15028

The investigational products are administrated orally, once in the morning every day, and each dose includes one tablet of investigational products (LXI-15028 50mg active agent or 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 weeks.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhaoshen Li, Doctor · Changhai Hospital Shanghai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2019-10-30
Completion
2019-11-26

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT03591653 on ClinicalTrials.gov