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Low recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-06 (High dosage) | Active Comparator | 18 mg (iv) in Day 1 as an induction dosage and 9 mg (iv) in Day 2 - 7 as a maintenance dosage |
|
| NPC-06 (Low dosage) | Active Comparator | 15 mg (iv) in Day 1 as an induction dosage and 6 mg (iv) in Day 2 - 7 as a maintenance dosage |
|
| Placebo | Placebo Comparator | Saline will be administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-06 | Drug | Patients will receive once a day for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Numeric Rating Scale (NRS) score within 2 hours after administration | Average change (slope) of NRS score | Pre-administration, 30, 60, 90 and 120 minutes post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13 |
| Time to event |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keio Hospital | Shinjuku-Ku | Tokyo | 160-8582 | Japan |
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Time to event analysis of analgesic effect
| 2 hours after initial administration to Day 7 |
| Improvement of Neuropathic Pain Symptom Inventory (NPSI) score | Change of NPSI score compared to baseline | 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 | Day 1 to Day 13 |
| Effective concentration | Blood phenytoin concentration | Day 0 to Day 13 |