임상 연구 문서 작성 및 출판 지원

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The primary endpoint is improvement in pain after treatment, as assessed by the investigator.

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The primary endpoint is the change from baseline in average daily pain intensity at Week 12, measured on the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable) and entered by the participant in the electronic diary each evening. The Week 12 value is the arithmetic mean of the daily scores recorded on Days 78 to 84; a participant with fewer than four daily scores in that window is handled as described in Section 9.4.

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One patient experienced liver problems during the study and the study drug was stopped. The patient recovered without any complications.

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On Day 34, a 57-year-old male participant had an alanine aminotransferase level of 412 U/L (10.3 times the upper limit of normal) with a total bilirubin of 1.4 mg/dL, and no rash, fever or eosinophilia. Study drug was permanently discontinued the same day. The event was graded CTCAE Grade 3, assessed by the investigator as probably related to study drug, and reported as serious because it required inpatient admission for observation from Day 35 to Day 39. Alanine aminotransferase returned to within the reference range by Day 61 with no further intervention.