Acute Pain in Herpes ZosterPhase 3NCT05480553
NPC-06 to Pain Associated With Acute Herpes Zoster
A Phase 3 study testing NPC-06 in people with Acute Pain in Herpes Zoster, run by Nobelpharma at 20 sites in Japan.
Trial summary
To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner. Read more about this study
- Who is it for?
- Ages 18 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
- 51 participants
- Where
- 20 sitesJapan
- Study dates
- 5 Aug 2022to 23 Aug 2023
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older at the time of informed consent.
- Patients who are male or female.
- Patients who are inpatient or outpatient.
- Patients who are diagnosed with herpes zoster and have acute pain.
- Patients who are within 28 days after the onset of herpes zoster.
- Patients whose mean NRS pain score is 4 or higher despite the use of the following drugs during the period between 24 hours and 120 minutes before the study drug administration. During this period, one or two of the following drugs should have been used, and the same drug should have been used at least twice.
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- Non-opioid analgesics (excluding its sustained release formulations and topical drugs used for other sites than the target site for efficacy)
- Ca2＋ channels α2δ ligands (excluding gabapentin)
- Tramadol (excluding its sustained release formulations)
- An extract from inflammatory rabbit skin inoculated by vaccinia virus
- Patients whose NRS pain score immediately before the study drug administration is 4 or higher.
- Patients who are able to perform NRS self-assessment appropriately. (9) Patients who gave written informed consent based on their own free will after receiving adequate explanation and fully understanding the details of the explanation in participating in the study.
Who cannot join
- Patients who are suspected to be increased intracranial pressure.
- Patients who are complicated with epilepsy, serious mental or neuropsychiatric disorders (including dementia, Parkinson's disease, or schizophrenia) or consciousness disturbance.
- Patients who are being treated for malignancy. However, those who do not interfere with daily life and have good general condition may be included in the study.
- Patients who are being treated for HIV infection or those who are receiving immunosuppressant (including biologics). However, those who do not interfere with daily life and have good general condition may be included in the study.
- Patients who are being treated for idiopathic trigeminal neuralgia.
- Patients who have other severe pain that may affect the assessment of pain associated with acute herpes zoster.
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- Patients who have received non-opioid analgesics (excluding its sustained release formulations and topical drugs used for other sites than the target site for efficacy), Ca2＋ channel-α2δ ligands (excluding gabapentin), tramadol (excluding its sustained release formulations), or an extract from inflammatory rabbit skin inoculated by vaccinia virus during the period from 120 minutes before the study drug administration to the start of study drug administration.
- Patients who have received the following drugs during the period from 24 hours before the study drug administration to immediately before the study drug administration.
- Non-opioid analgesics (its sustained release formulations)
- Gabapentin
- Tramadol (its sustained release formulations)
- Opioid analgesics
- Steroidal anti-inflammatory drugs (systemic) for treatment of herpes zoster and pain associated with acute herpes zoster.
- Antidepressants, antiarrhythmics (excluding those in Vaughan Williams class Ⅱ), NMDA receptor antagonists, centrally acting muscle relaxants, and anesthetics (excluding topical drugs used for other sites than the target site for efficacy).
- Patients who have sinus bradycardia or advanced conduction disturbance.
- Patients who have a history of hypersensitivity to hydantoin.
- Patients who are receiving drugs that are contraindicated in the package insert for fosphenytoin.
- Patients who have received amenamevir during the period from 24 hours before the study drug administration to immediately before the study drug administration.
- Patients who are complicated with meningitis or have symptoms of meningeal irritation.
- Patients who have serious cardiac disease, respiratory disorder, or hepatic or renal dysfunction (as a guide, seriousness corresponding to Grade 3 of "Standards for Classification of Seriousness of Adverse Drug Reactions (Notification No. 80 of the Pharmaceutical Safety Notification ").
- Patients who are receiving fosphenytoin, phenytoin, ethotoin, or a combination of these drugs or have received these drugs as adjuvant analgesics.
- Patients who have participated in other clinical study within 3 months of the date of the screening test.
- Pregnant women, lactating women or patients of childbearing potential during the study period.
- Patients who are unable to give appropriate contraception in accordance with the instructions of the investigator or sub-investigator (hereafter, the investigators) during the period from after obtaining informed consent to the end of the follow-up period.
- Other patients who are deemed inappropriate for participation in the study by the investigators.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo
University of Yamanashi Hospital
Chūō, Yamanashi
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa
Fukuoka Kinen Hospital
Fukuoka
Hakata Pain Clinic
Fukuoka
Matsuda Tomoko Dermatological Clinic
Fukuoka
Hakodate Central General Hospital
Hakodate, Hokkaido
Japanese Red Cross Society Himeji Hospital
Himeji, Hyōgo
National Hospital Organization Kanazawa Medical Center
Kanazawa
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka
Koga General Hospital
Koga, Ibaraki
Chugoku Rosai Hospital
Kure, Hiroshima
Kurobe City Hospital
Kurobe-shi, Toyama
University Hospital Kyoto Prefectural University of Medicine
Kyoto
Sumi Clinic Dermatology Allergology
Meguro City, Tokyo
Toyama Dermatologic Clinic
Nichinan, Miyazaki
Kawasaki Medical School General Medical Center
Okayama
Shizuoka City Shizuoka Hospital
Shizuoka
Yoshikawa Skin Clinic
Takatsuki, Osaka
Akemi Dermatology Clinic
Urayasu, Chiba
About this study
Official title: A Phase 3, Placebo-Controlled, Double-Blind Controlled Study of NPC-06 in Patients With Pain Associated With Acute Herpes Zoster
To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner.
Read the detailed description
The eligible patients will be randomized into two groups, and will receive NPC-06 or placebo.
- Conditions
- Acute Pain in Herpes Zoster
- Being tested
- NPC-06, Placebo
- Keywords
- Herpes zoster, fosphenytoin, adjuvant analgesic, acute pain, NPC-06
- Medical subject headings
- Herpes Zoster, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-06Drug
- Initial dose (Day 1) <Dose> An 18 mg/kg of NPC-06 will be injected by intravenous drip infusion once daily. The maximum dose of the test drug should not exceed 1,200 mg as fosphenytoin sodium. <Administration method> Dilute the study drug 3 to 4-fold using physiological saline for intravenous infusion and then administer the solution over 18 minutes.
- Maintenance dose(Day 2～7) Maintenance dose on the next day (Day 2) after the initial dose will be mandatory, and will be dosed up to 6 days. Maintenance dose on Day 3 and thereafter will follow the transition criteria for maintenance dose.
<Dose> A 7.5 mg/kg of NPC-06 will be injected as needed by intravenous drip infusion once daily. The maximum dose of NPC-06 should not exceed 500 mg as fosphenytoin sodium.
<Administration method> Dilute the study drug 3-to 4-fold using physiological saline for intravenous infusion and then administer the solution over 7 minutes and 30 seconds.
PlaceboDrug
- Initial dose (Day 1) <Dose> A placebo will be injected by intravenous drip infusion once daily. <Administration method> Dilute the study drug 3 to 4-fold using physiological saline for intravenous infusion and then administer the solution over 18 minutes.
- Maintenance dose(Day 2～7) Maintenance dose on the next day (Day 2) after the initial dose will be mandatory, and will be dosed up to 6 days. Maintenance dose on Day 3 and thereafter will follow the transition criteria for maintenance dose.
<Dose> A placebo will be injected as needed by intravenous drip infusion once daily. Dilute the study drug 3-to 4-fold using physiological saline for intravenous infusion and then administer the solution over 7 minutes and 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| NPC-06 | Experimental | Not described Receives: Drug: NPC-06 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Change in the NRS pain score from baseline at 120 minutes after the study drug administration.
Measured: 120 minutes after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start5 Aug 2022
- Primary completion29 May 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480553
- Sponsor's protocol ID
- NPC-06-6
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Placebo-Controlled, Double-Blind Controlled Study of NPC-06 in Patients With Pain Associated With Acute Herpes Zoster
- ClinicalTrials.gov ID
- NCT05480553
- Acronym / sponsor ID
- NPC-06-6
- Conditions
- Acute Pain in Herpes Zoster
- Keywords
- Herpes zoster, fosphenytoin, adjuvant analgesic, acute pain, NPC-06
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 29 Jul 2022 (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.
To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner.
Detailed description
The eligible patients will be randomized into two groups, and will receive NPC-06 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPC-06 | Experimental | Drug: NPC-06 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged 18 years or older at the time of informed consent.
- Patients who are male or female.
- Patients who are inpatient or outpatient.
- Patients who are diagnosed with herpes zoster and have acute pain.
- Patients who are within 28 days after the onset of herpes zoster.
Key exclusion criteria (25 listed)
- Patients who are suspected to be increased intracranial pressure.
- Patients who are complicated with epilepsy, serious mental or neuropsychiatric disorders (including dementia, Parkinson's disease, or schizophrenia) or consciousness disturbance.
- Patients who are being treated for malignancy. However, those who do not interfere with daily life and have good general condition may be included in the study.
- Patients who are being treated for HIV infection or those who are receiving immunosuppressant (including biologics). However, those who do not interfere with daily life and have good general condition may be included in the study.
- Patients who are being treated for 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-061. Initial dose (Day 1) <Dose> An 18 mg/kg of NPC-06 will be injected by intravenous drip infusion once daily. The maximum dose of the test drug should not exceed 1,200 mg as fosphenytoin sodium. <Administration method> Dilute the study drug 3 to 4-fold using physiological saline for intravenous infusion and then administer the solution over 18 minutes. 2. Maintenance dose(Day 2～7) Maintenance dose on the next day (Day 2) after the initial dose will be mandatory, and will be dosed up to 6 days. Maintenance dose on Day 3 and thereafter will follow the transition criteria for maintenance dose. <Dose> A 7.5 mg/kg of NPC-06 will be injected as needed by intravenous drip infusion once daily. The maximum dose of NPC-06 should not exceed 500 mg as fosphenytoin sodium. <Administration method> Dilute the study drug 3-to 4-fold using physiological saline for intravenous infusion and then administer the solution over 7 minutes and 30 seconds. | Drug | NPC-06 |
| Placebo1. Initial dose (Day 1) <Dose> A placebo will be injected by intravenous drip infusion once daily. <Administration method> Dilute the study drug 3 to 4-fold using physiological saline for intravenous infusion and then administer the solution over 18 minutes. 2. Maintenance dose(Day 2～7) Maintenance dose on the next day (Day 2) after the initial dose will be mandatory, and will be dosed up to 6 days. Maintenance dose on Day 3 and thereafter will follow the transition criteria for maintenance dose. <Dose> A placebo will be injected as needed by intravenous drip infusion once daily. Dilute the study drug 3-to 4-fold using physiological saline for intravenous infusion and then administer the solution over 7 minutes and 30 seconds. | Drug | Placebo |
Primary outcome
The change of NRS (Numeric Rating Scale:Max10, Min0, higher scores mean a worse outcome) score
Time frame: 120 minutes after first administration
Change in the NRS pain score from baseline at 120 minutes after the study drug administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPC-06 in people with Acute Pain in Herpes Zoster, run by Nobelpharma at 20 sites 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 12 inclusion and 25 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: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 change 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?
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 28 Sep 2023.