Non-erosive Reflux Disease Clinical Trial
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
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.
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