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
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|ClinicalTrials.gov Identifier: NCT03591653|
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : November 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-erosive Reflux Disease||Drug: LXI-15028 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||October 29, 2018|
|Estimated Primary Completion Date :||November 5, 2019|
|Estimated Study Completion Date :||April 30, 2020|
|Experimental: LXI-15028 50mg group||
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.
|Placebo Comparator: Placebo group||
- 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.
- Resolution of main symptoms [ Time Frame: 2 week after receiving oral doses ]Resolution rate of main symptoms (heartburn, regurgitation) at Week 2: percentage of patients with complete resolution of main symptoms (for consecutive 7 days) at Week 2. The main symptoms are evaluated using RDQ.
- Symptom improvement [ Time Frame: 4 weeks after receiving oral doses ]Change of Reflux Disease Questionnaire (RDQ) score (including severity score and frequency score) of each post-treatment visit from baseline;Symptom assessment based on subject diary;
- Life quality improvement [ Time Frame: 4 weeks after receiving oral doses ]Change of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score of each post-treatment visit from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591653
|Contact: Lin Zhang, Masteremail@example.com|
|Shanghai East Hospital||Recruiting|
|Shanghai, Shanghai, China, 200120|
|Contact: Fei Liu, Doctor 13301921052 firstname.lastname@example.org|
|Contact: Yedong Hu, Master 18121247026 email@example.com|
|Principal Investigator:||Zhaoshen Li, Doctor||Changhai Hospital Shanghai|