Phase II Clinical Trial of NPC-06 in Patients With Neuropathic Pain in Cancer

NCT03773055 | Terminated Phase 2

• 1 other identifier: NPC-06-4
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain in Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (3)

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

Drug: NPC-06

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

Drug: NPC-06

Placebo

PLACEBO COMPARATOR

Saline will be administered intravenously

Drug: NPC-06

Interventions

NPC-06 DRUG

Patients will receive once a day for 7 days.

NPC-06 (High dosage); NPC-06 (Low dosage); Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 4.
• Patients who average number of daily rescue medication use during observation period is less than 6.
• Patients who are predicted to survive longer than 3 month.
• Patients who ECOG Performance Status (PS) score is 0 to 3.
• Patients who (or whose legally acceptable representative if the patient is underage) provide a written consent at their own will with a full understanding after receiving a sufficient explanation on participation in the study

You may not qualify if:

• 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.
• Patients who have complications such as serious heart disease, hepatic function disorder or renal function disorder which severity are considered by investigator as grade 3 or more severe with reference to ''Concerning classification criteria for seriousness of adverse drug reactions of medical agents'' (except cancer).
• Patients who received surgical treatment or internal radiation therapy in past three month before the first day of pre observation period.
• Patients who are treated nerve block, radiation therapy, spinal cord stimulation or surgical treatment for the part of neuropathic pain in past one month before the first day of pre observation period.
• Patients who change the usage or dosage of medication for cancer as primal disease in the past two week before the first day of the pre observation period, or patients who are predicted not to continue the treatment without change in the medication while this clinical trial.
• Patients who are administrating with fosphenytoin, phenytoin or ethotoin or have taken these drugs as medication for neuropathic pain.

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (1)

Keio Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: April 3, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)