The purpose of this trial is to investigate the efficiency of pain relief and the safety of NPC-06 for the neuropathic pain associated with cancer, in addition to explore the effective concentration of NPC-06.
The eligible patients will be randomized into three groups, and will receive NPC-06 (high dose), NPC-06 (low dose) or placebo once a day for 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
Patients will receive once a day for 7 days.
Keio Hospital
Shinjuku-Ku, Tokyo, Japan
Improvement of Numeric Rating Scale (NRS) score within 2 hours after administration
Average change (slope) of NRS score
Time frame: Pre-administration, 30, 60, 90 and 120 minutes post-administration
Other improvements of NRS score
Change of NRS score, Change of NRS score of persistent pain, Change of maximum pain, at the time of evaluation compared to baseline
Time frame: Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13
Time to event
Time to event analysis of analgesic effect
Time frame: 2 hours after initial administration to Day 7
Improvement of Neuropathic Pain Symptom Inventory (NPSI) score
Change of NPSI score compared to baseline
Time frame: Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13
Rescue medication use
Number of times of rescue medication use
Time frame: Day 1 to Day 13
Effective concentration
Blood phenytoin concentration
Time frame: Day 0 to Day 13
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.