Neuropathic Pain in CancerPhase 2NCT03773055
Phase II Clinical Trial of NPC-06 in Patients With Neuropathic Pain in Cancer
A Phase 2 study testing NPC-06 in people with Neuropathic Pain in Cancer, 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 neuropathic pain associated with cancer, in addition to explore the effective concentration of NPC-06. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neuropathic Pain in Cancer
- 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
- 7 participants
- Where
- 1 siteJapan
- Study dates
- 3 Apr 2019to 30 Sep 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 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.
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- 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
Who cannot join
- 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.
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- 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.
- 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.
- Female patients who are pregnant or lactating or who may be pregnancy in the period of the clinical trial.
- Patients who can not agree to prevent contraception appropriately following the direction of the Investigator or the sub-investigator.
- Any other patients who are considered by the investigator as unsuitable for participation in the trial.
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 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.
Read the 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.
- Conditions
- Neuropathic Pain in Cancer
- 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
Patients will receive once a day for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: NPC-06 |
| Placebo | Placebo comparator | Saline will be administered intravenously Receives: Drug: NPC-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Numeric Rating Scale (NRS) score within 2 hours after administration
Average change (slope) of NRS score
Measured: Pre-administration, 30, 60, 90 and 120 minutes post-administration
Secondary outcomes (5)
Other improvements of NRS score
Change of NRS score, Change of NRS score of persistent pain, Change of maximum pain, at the time of evaluation compared to baseline
Measured: Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13
Time to event
Time to event analysis of analgesic effect
Measured: 2 hours after initial administration to Day 7
Improvement of Neuropathic Pain Symptom Inventory (NPSI) score
Change of NPSI score compared to baseline
Measured: Pre-dose, Days 1,2,3,4,5,6,7,8,9,10,11,12,13
Rescue medication use
Number of times of rescue medication use
Measured: Day 1 to Day 13
Effective concentration
Blood phenytoin concentration
Measured: Day 0 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start3 Apr 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain in CancerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773055
- Sponsor's protocol ID
- NPC-06-4
- Status last verified
- Aug 2020
- First submitted
- 10 Dec 2018
- Last updated
- 16 Nov 2020
- 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 16 Nov 2020. 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 in Patients With Neuropathic Pain in Cancer
- ClinicalTrials.gov ID
- NCT03773055
- Acronym / sponsor ID
- NPC-06-4
- Conditions
- Neuropathic Pain in Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Dec 2018 (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 neuropathic pain associated with cancer, in addition to explore the effective concentration of NPC-06.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPC-06 (High dosage) | Active comparator | Drug: NPC-0618 mg (iv) in Day 1 as an induction dosage and 9 mg (iv) in Day 2 - 7 as a maintenance dosage |
| NPC-06 (Low dosage) | Active comparator | Drug: NPC-0615 mg (iv) in Day 1 as an induction dosage and 6 mg (iv) in Day 2 - 7 as a maintenance dosage |
| Placebo | Placebo comparator | Drug: NPC-06Saline will be administered intravenously |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 16 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
Key exclusion criteria (19 listed)
- 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.
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-06Patients will receive once a day for 7 days. | Drug | NPC-06 (High dosage), NPC-06 (Low dosage), Placebo |
Primary outcome
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
5 secondary outcomes
Other improvements of NRS score
Time frame: 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
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
Rescue medication use
Time frame: Day 1 to Day 13
Effective concentration
Time frame: Day 0 to Day 13
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 16 Nov 2020.
- 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.
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 Neuropathic Pain in Cancer, 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 19 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 16 Nov 2020. 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?
Improvement of Numeric Rating Scale (NRS) score within 2 hours after administration (time frame: Pre-administration, 30, 60, 90 and 120 minutes post-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 16 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.