Spinal Disorder Clinical Trial
Official title:
A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of NORSPAN® (Buprenorphine) in Korean Patients With Spinal Disorders (NOBLE)
The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of
NORSPAN® from baseline.
And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0)
the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's
overall satisfaction, and safety
Upon providing written informed consent, subject will be screened in the study and
assessment will be performed at that time such as safety laboratory assessments, physical
examination, vital sign, medical history taking, 24 hours pain intensity score, EQ-5D, pain
and sleep questionnaire, physician's overall satisfaction and subject's overall
satisfaction.
If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient
will receive treatment with NORSPAN®.
Treatment with NORSPAN® will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper
titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to
the investigator's decision.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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