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
Overview
- Phase
- Phase 3
- Intervention
- LXI-15028 50mg group
- Conditions
- Duodenal Ulcer
- Sponsor
- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Cumulative endoscopic healing rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Arms & Interventions
LXI-15028 50mg group(n=200)
Intervention: LXI-15028 50mg group
Lansoprazole 30mg group (n=200)
Intervention: Lansoprazole 30mg group
Outcomes
Primary Outcomes
Cumulative endoscopic healing rate
Time Frame: 4 or 6 weeks after receiving oral doses
Secondary Outcomes
- 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)