Acute Pain in Herpes ZosterPhase 2NCT04139330
NPC-06 to Acute Pain in Herpes Zoster
A Phase 2 study testing NPC-06 in people with Acute Pain in Herpes Zoster, run by Nobelpharma at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Pain in Herpes Zoster
- What is being tested?
- NPC-06
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- 21 Nov 2019to 28 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Pain in Herpes Zoster
- Being tested
- NPC-06
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-06Drug
Infuse NPC-06 intravenously
| Study group | Role | What they receive |
|---|---|---|
| NPC-06 (high dose) | Experimental | Infuse diluted NPC-06 18mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 18 minutes. Receives: Drug: NPC-06 |
| NPC-06 (low dose) | Experimental | Infuse diluted NPC-06 12mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 12 minutes Receives: Drug: NPC-06 |
| NPC-06 (placebo) | Placebo comparator | Infuse NPC-06 (placebo) over 12 minutes or 18 minutes Receives: Drug: NPC-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes after first administration
Secondary outcomes (3)
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.
Measured: 120 minutes after first administration
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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start21 Nov 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pain in Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139330
- Sponsor's protocol ID
- NPC-06-5
- Status last verified
- Jun 2020
- First submitted
- 18 Oct 2019
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iseki M, Yamamoto T, Ogawa Y, Majima Y, Abe Y, Watanabe D, Amaya F, Hasegawa T, Inafuku K, Kosugi T, Nomura Y, Deguchi T, Hamada T, Shimizu K, Arai S, Takahashi M, Hamada I, Ishikawa Y, Kawashima M. Efficacy and safety of intravenous fosphenytoin for patients with acute herpes zoster-associated pain: A placebo-controlled randomized trial. J Dermatol. 2024 Feb;51(2):234-242. doi: 10.1111/1346-8138.17054. Epub 2023 Dec 27.
PubMed 38149403
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04139330
- Acronym / sponsor ID
- NPC-06-5
- Conditions
- Acute Pain in Herpes Zoster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPC-06 (high dose) | Experimental | Drug: NPC-06Infuse diluted NPC-06 18mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 18 minutes. |
| NPC-06 (low dose) | Experimental | Drug: NPC-06Infuse diluted NPC-06 12mg/kg solution with 3 to 4 times volume of saline. Administarate NPC-06 gradually (slowly) over 12 minutes |
| NPC-06 (placebo) | Placebo comparator | Drug: NPC-06Infuse NPC-06 (placebo) over 12 minutes or 18 minutes |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPC-06Infuse NPC-06 intravenously | Drug | NPC-06 (high dose), NPC-06 (low dose), NPC-06 (placebo) |
Primary outcome
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Time frame: 120 minutes after first administration
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.
3 secondary outcomes
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Time frame: 120 minutes after first administration
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Time frame: 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
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Derived from this study: PubMed 38149403Iseki M, Yamamoto T, Ogawa Y, Majima Y, Abe Y, Watanabe D, Amaya F, Hasegawa T, Inafuku K, Kosugi T, Nomura Y, Deguchi T, Hamada T, Shimizu K, Arai S, Takahashi M, Hamada I, Ishikawa Y, Kawashima M. Efficacy and safety of intravenous fosphenytoin for patients with acute herpes zoster-associated pain: A placebo-controlled randomized trial. J Dermatol. 2024 Feb;51(2):234-242. doi: 10.1111/1346-8138.17054. Epub 2023 Dec 27.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NPC-06 in people with Acute Pain in Herpes Zoster, run by Nobelpharma at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score (time frame: 120 minutes after first administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.