A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Group Trial to Investigate the Proof of Concept of NPC-06 in Patients With Neuropathic Pain in Cancer

Nobelpharma1 site in 1 country7 target enrollmentApril 3, 2019

ConditionsNeuropathic Pain in Cancer

InterventionsNPC-06

DrugsNPC-06

Overview

Phase: Phase 2
Intervention: NPC-06
Conditions: Neuropathic Pain in Cancer
Sponsor: Nobelpharma
Enrollment: 7
Locations: 1
Primary Endpoint: Improvement of Numeric Rating Scale (NRS) score within 2 hours after administration
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

April 3, 2019

End Date

September 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nobelpharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•16 years old or greater at the time of informed consent
•Both genders
•Patients who can admit to hospital for all assessment duration from first administration until the next day of final administration. (including the hospitalized patient )
•Patients who are diagnosed and informed as cancer (including sarcoma, lymphoma and multiple myeloma)
•Patients who are diagnosed as neuropathic pain by neurological examination and imaging findings
•Patients who NRS score of average persistent pain is higher than 4, even they were treated with level 3 of WHO three-step analgesic ladder at the observation period.
•Patients who NRS score at the time of first administration and NRS score of persistent pain in the past 24 hours are higher than
•Patients who average number of daily rescue medication use during observation period is less than
•Patients who are predicted to survive longer than 3 month.
•Patients who ECOG Performance Status (PS) score is 0 to

Exclusion Criteria

•Patients who can not evaluate NRS by themselves.
•Patients who have leukemia as a complication.
•Patients who have a primary brain neoplasm or a metastatic brain neoplasm as a complication.
•Patients who have epilepsy, serious psychiatric or neurological disease ( i. e. dementia, Parkinson disease or schizophrenic disorder) or consciousness disturbance as a complication.
•Patients who have primary trigeminal neuralgia, diabetic neuropathy, post herpetic neuralgia or acute herpes zoster pain as a complication.
•Patients who has other serious pain which affect the evaluation of neuropathic pain in cancer.
•Patients who have sinus bradycardia or serious disturbance of conduction system.
•Patients who have history of hypersensitivity against hydantoin compound.
•Patients who are administrated tadalafil (for pulmonary hypertension), rilpivirine, asunaprevir, daclatasvir, vaniprevir, macitentan or sofosbuvir.
•Patients who are administrated methadone.

Arms & Interventions

NPC-06 (High dosage)

18 mg (iv) in Day 1 as an induction dosage and 9 mg (iv) in Day 2 - 7 as a maintenance dosage

Intervention: NPC-06

NPC-06 (Low dosage)

15 mg (iv) in Day 1 as an induction dosage and 6 mg (iv) in Day 2 - 7 as a maintenance dosage

Intervention: NPC-06

Placebo

Saline will be administered intravenously

Intervention: NPC-06

Outcomes

Primary Outcomes

Improvement of Numeric Rating Scale (NRS) score within 2 hours after administration

Time Frame: Pre-administration, 30, 60, 90 and 120 minutes post-administration

Average change (slope) of NRS score

Secondary Outcomes

Other improvements of NRS score(Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13)
Time to event(2 hours after initial administration to Day 7)
Improvement of Neuropathic Pain Symptom Inventory (NPSI) score(Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13)
Rescue medication use(Day 1 to Day 13)
Effective concentration(Day 0 to Day 13)