A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 in the Treatment of Non-erosive Reflux Disease in Chinese Patients for 4 Weeks
Overview
- Phase
- Phase 3
- Intervention
- LXI-15028
- Conditions
- Non-erosive Reflux Disease
- Sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- Enrollment
- 291
- Locations
- 1
- Primary Endpoint
- Resolution of main symptoms
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject who volunteers to sign the written informed consent form approved by the independent 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.
- •Having experienced heartburn (burning or pain behind the breastbone) and regurgitation (acid taste in the mouth and discomfort movement of materials upwards from the stomach) symptoms at least three months prior to screening.
- •Having experienced heartburn and regurgitation within 7 days prior to screening, with the frequency and severity in symptom assessment meeting at least one of the following items:
- •Mild heartburn for at least 2 days, with regurgitation;
- •Mild regurgitation for at least 2 days, with heartburn;
- •Moderate or more severe heartburn for at least 1 day, with regurgitation;
- •Moderate or more severe regurgitation for at least 1 day, with heartburn. (Note: To be determined by using the RDQ \[item a, b, e, f\] completed by subject.) And the RDQ symptom assessment before randomization (Visit 2) still meets the above criteria.
- •Within 14 days before study initiation, the subject has been confirmed with no mucosal damage through upper gastrointestinal endoscopy based on Los Angeles (LA) classification. And non-erosive reflux disease is clinically diagnosed by the investigator.
Exclusion Criteria
- •Subject who had participated in this study previously, or had participated in other P-CAB drug clinical studies.
- •Participation in other clinical study within 3 months prior to screening, 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 and participated in another study (NC821602) sponsored by this sponsor in the same study site, but had been withdrawn from that study prior to the start of any treatment.
- •Subjects who participate in the plan or conduction of this study (e.g., the sponsor or staff of the study site).
- •Women who are pregnant or lactating.
- •Subject who is known to be allergic to the active ingredient or Talcid® of the investigational product (including esomeprazole).
- •Subject who is unable to undertake an upper gastrointestinal endoscopy.
- •Subject who is unable to complete the subject's diary by oneself.
- •Subject who has history of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder or other mental disorder.
Arms & Interventions
LXI-15028 50mg group
Intervention: LXI-15028
Placebo group
Intervention: Placebo
Outcomes
Primary Outcomes
Resolution of main symptoms
Time Frame: 4 weeks after receiving oral doses
Resolution rate of main symptoms (heartburn, regurgitation) at Week 4: percentage of patients with complete resolution of main symptoms (for consecutive 7 days) at Week 4. Note: At Week 4, Reflux Disease Questionnaire (RDQ) (item a, b, e, f) is used to evaluate all main symptoms during previous consecutive 7 days. Complete resolution is defined as the main symptoms are completely resolved and do not occur.
Secondary Outcomes
- Resolution of main symptoms(2 week after receiving oral doses)
- Symptom improvement(4 weeks after receiving oral doses)
- Life quality improvement(4 weeks after receiving oral doses)