NPC-06 to Acute Pain in Herpes Zoster
Primary Purpose
Acute Pain in Herpes Zoster
Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
NPC-06
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain in Herpes Zoster
Eligibility Criteria
Inclusion Criteria:
- 20 years old or over at the time of informed consent.
- Both genders.
- Patients who have acute rash (either erythema or papule or bulla or pustule, or more), except who have crust more than 20% of entire rash at just before the time of the first administration.
- Patients who are administrated antiviral drug for herpes zoster at the time of the first administration.
- Patients who are administrated non-opioid analgesics(acetaminophen, NSAIDs) for herpes zoster at the time of the first administration.
Patients who the NRS score at the time of below evaluation point is higher than 4.
- 120 minutes before the start of infusion.
- Just before the start of infusion.
- Patients who the therapeutic effect of non-opioid analgesics for herpes zoster has been insufficient.
- Patients who can admit to hospital for the all assessment duration from first administration until next day (including hospitalized patient).
- Patients or his/her guardian who give a written informed consent in understanding and willingness after having received enough explanation regarding the study participation.
Exclusion Criteria:
- Patients who cannot evaluate NRS by themselves.
- Patients who are suspected to intracranial pressure increase.
- Patients who have epilepsy, serious psychiatric or serious neurological disease (i. e. dementia, Parkinson disease and schizophrenic disorder) or consciousness disorder.
- Patients who have malignant tumors (except for patients who have no signs of recurrence under treatment) or patients who are under treatment for HIV or patients who are receiving immunosuppressant.
- Patients who have complicated idiopathic trigeminal neuralgia.
- Patients who have other serious pain which may affect the evaluation of acute herpetic pain.
- Patients who are receiving opioids or steroids(systemic).
- Patients who have sinus bradycardia or serious disturbance of conduction system.
- Patients who have history of hypersensitivity against hydantoin compound.
- Patients who are receiving tadalafil (for pulmonary hypertension), rilpivirine, asunaprevir, daclatasvir, vaniprevir, macitentan or sofosbuvir.
- Patients who are receiving medications for neuropathic pain, antidepressants, antiarrhythmic drugs, N-methyl-D-aspartate receptor antagonists, muscle relaxants, local anesthetics, an extract from inflammatory rabbit skin inoculated by vaccinia virus, Chinese herbal medications for analgesia, vitamin B12.
- Patients who are receiving amenamevir.
- Patients who have meningitis or meningeal irritation signs.
- 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'' .
- Patients who are receiving fosphenytoin, phenytoin or ethotoin and combination drug including these or have taken these drugs as adjuvant therapy for pain .
Sites / Locations
- Kawasaki Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
NPC-06 (high dose)
NPC-06 (low dose)
NPC-06 (placebo)
Arm Description
Infuse diluted NPC-06 18mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 18 minutes.
Infuse diluted NPC-06 12mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 12 minutes
Infuse NPC-06 (placebo) over 12 minutes or 18 minutes
Outcomes
Primary Outcome Measures
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
The average change (slope) of NRS score at the time of evaluation, which is measured before the first administration, 30, 60, 90 and 120 minutes after the first administration.
Secondary Outcome Measures
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
The change of NRS score at the time of evaluation compared to baseline.
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
The ratio of subjects who improve 2 or more points compared to baseline at 120 minutes after first administration.
The improvement of QOL(EQ-5D-5L, Max 1.000, Min -0.111, higher scores mean a better outcome) score
The change of QOL score at the time of evaluation compared to baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04139330
Brief Title
NPC-06 to Acute Pain in Herpes Zoster
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled Parallel Group Trial to Investigate the Proof of Concept of NPC-06 to Acute Pain in Herpes Zoster
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to investigate the efficiency of pain relief and the safety of NPC-06 for the acute pain in herpes zoster in the placebo-controlled double-blind parallel group trial, in addition to explore the effective concentration of NPC-06.
Detailed Description
The eligible patients will be randomized into three groups, and will receive single doses of NPC-06 (high dose and low dose) or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain in Herpes Zoster
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPC-06 (high dose)
Arm Type
Experimental
Arm Description
Infuse diluted NPC-06 18mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 18 minutes.
Arm Title
NPC-06 (low dose)
Arm Type
Experimental
Arm Description
Infuse diluted NPC-06 12mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 12 minutes
Arm Title
NPC-06 (placebo)
Arm Type
Placebo Comparator
Arm Description
Infuse NPC-06 (placebo) over 12 minutes or 18 minutes
Intervention Type
Drug
Intervention Name(s)
NPC-06
Intervention Description
Infuse NPC-06 intravenously
Primary Outcome Measure Information:
Title
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Description
The average change (slope) of NRS score at the time of evaluation, which is measured before the first administration, 30, 60, 90 and 120 minutes after the first administration.
Time Frame
120 minutes after first administration
Secondary Outcome Measure Information:
Title
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Description
The change of NRS score at the time of evaluation compared to baseline.
Time Frame
120 minutes after first administration
Title
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Description
The ratio of subjects who improve 2 or more points compared to baseline at 120 minutes after first administration.
Time Frame
120 minutes after first administration
Title
The improvement of QOL(EQ-5D-5L, Max 1.000, Min -0.111, higher scores mean a better outcome) score
Description
The change of QOL score at the time of evaluation compared to baseline.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20 years old or over at the time of informed consent.
Both genders.
Patients who have acute rash (either erythema or papule or bulla or pustule, or more), except who have crust more than 20% of entire rash at just before the time of the first administration.
Patients who are administrated antiviral drug for herpes zoster at the time of the first administration.
Patients who are administrated non-opioid analgesics(acetaminophen, NSAIDs) for herpes zoster at the time of the first administration.
Patients who the NRS score at the time of below evaluation point is higher than 4.
120 minutes before the start of infusion.
Just before the start of infusion.
Patients who the therapeutic effect of non-opioid analgesics for herpes zoster has been insufficient.
Patients who can admit to hospital for the all assessment duration from first administration until next day (including hospitalized patient).
Patients or his/her guardian who give a written informed consent in understanding and willingness after having received enough explanation regarding the study participation.
Exclusion Criteria:
Patients who cannot evaluate NRS by themselves.
Patients who are suspected to intracranial pressure increase.
Patients who have epilepsy, serious psychiatric or serious neurological disease (i. e. dementia, Parkinson disease and schizophrenic disorder) or consciousness disorder.
Patients who have malignant tumors (except for patients who have no signs of recurrence under treatment) or patients who are under treatment for HIV or patients who are receiving immunosuppressant.
Patients who have complicated idiopathic trigeminal neuralgia.
Patients who have other serious pain which may affect the evaluation of acute herpetic pain.
Patients who are receiving opioids or steroids(systemic).
Patients who have sinus bradycardia or serious disturbance of conduction system.
Patients who have history of hypersensitivity against hydantoin compound.
Patients who are receiving tadalafil (for pulmonary hypertension), rilpivirine, asunaprevir, daclatasvir, vaniprevir, macitentan or sofosbuvir.
Patients who are receiving medications for neuropathic pain, antidepressants, antiarrhythmic drugs, N-methyl-D-aspartate receptor antagonists, muscle relaxants, local anesthetics, an extract from inflammatory rabbit skin inoculated by vaccinia virus, Chinese herbal medications for analgesia, vitamin B12.
Patients who are receiving amenamevir.
Patients who have meningitis or meningeal irritation signs.
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'' .
Patients who are receiving fosphenytoin, phenytoin or ethotoin and combination drug including these or have taken these drugs as adjuvant therapy for pain .
Facility Information:
Facility Name
Kawasaki Hospital
City
Okayama city
State/Province
Okayama
ZIP/Postal Code
700-8505
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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NPC-06 to Acute Pain in Herpes Zoster
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