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

November 12, 2020 updated by: Nobelpharma

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 16 years old or greater at the time of informed consent
  2. Both genders
  3. Patients who can admit to hospital for all assessment duration from first administration until the next day of final administration. (including the hospitalized patient )
  4. Patients who are diagnosed and informed as cancer (including sarcoma, lymphoma and multiple myeloma)
  5. Patients who are diagnosed as neuropathic pain by neurological examination and imaging findings
  6. 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.
  7. 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.
  8. Patients who average number of daily rescue medication use during observation period is less than 6.
  9. Patients who are predicted to survive longer than 3 month.
  10. Patients who ECOG Performance Status (PS) score is 0 to 3.
  11. 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

Exclusion Criteria:

  1. Patients who can not evaluate NRS by themselves.
  2. Patients who have leukemia as a complication.
  3. Patients who have a primary brain neoplasm or a metastatic brain neoplasm as a complication.
  4. Patients who have epilepsy, serious psychiatric or neurological disease ( i. e. dementia, Parkinson disease or schizophrenic disorder) or consciousness disturbance as a complication.
  5. Patients who have primary trigeminal neuralgia, diabetic neuropathy, post herpetic neuralgia or acute herpes zoster pain as a complication.
  6. Patients who has other serious pain which affect the evaluation of neuropathic pain in cancer.
  7. Patients who have sinus bradycardia or serious disturbance of conduction system.
  8. Patients who have history of hypersensitivity against hydantoin compound.
  9. Patients who are administrated tadalafil (for pulmonary hypertension), rilpivirine, asunaprevir, daclatasvir, vaniprevir, macitentan or sofosbuvir.
  10. Patients who are administrated methadone.
  11. 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).
  12. Patients who received surgical treatment or internal radiation therapy in past three month before the first day of pre observation period.
  13. 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.
  14. 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.
  15. Patients who are administrating with fosphenytoin, phenytoin or ethotoin or have taken these drugs as medication for neuropathic pain.
  16. Patients who have participated in other clinical trial and have taken a trial drug in past three month before the first day of pre observation period.
  17. Female patients who are pregnant or lactating or who may be pregnancy in the period of the clinical trial.
  18. Patients who can not agree to prevent contraception appropriately following the direction of the Investigator or the sub-investigator.
  19. Any other patients who are considered by the investigator as unsuitable for participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Saline will be administered intravenously
Drug: NPC-06
Patients will receive once a day for 7 days.
Active Comparator: 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
Drug: NPC-06
Patients will receive once a day for 7 days.
Active Comparator: 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
Drug: NPC-06
Patients will receive once a day for 7 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Pre-administration, 30, 60, 90 and 120 minutes post-administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other improvements of NRS score
Time Frame: Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13
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
Time Frame: 2 hours after initial administration to Day 7
Time to event analysis of analgesic effect
2 hours after initial administration to Day 7
Improvement of Neuropathic Pain Symptom Inventory (NPSI) score
Time Frame: Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13
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
Time Frame: Day 1 to Day 13
Number of times of rescue medication use
Day 1 to Day 13
Effective concentration
Time Frame: Day 0 to Day 13
Blood phenytoin concentration
Day 0 to Day 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nobelpharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPC-06-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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