Dysmenorrhea Clinical Trial
Official title:
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.
The main objective of this study is to confirm the effectiveness and safety profile of
NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary
dysmenorrhea).
Additionally we also investigate the differences of effectiveness of NPC-01 in comparison
with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is
already marketed at them.
To achieve these, closed testing procedure is used in this study. After confirming
statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified
analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary
dysmenorrhea (NPC-01, IKH-01 and Placebo).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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