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

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ClinicalTrials.gov Identifier: NCT03773055
Recruitment Status : Terminated (Low recruitment)
First Posted : December 12, 2018
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date November 16, 2020
Actual Study Start Date  ICMJE April 3, 2019
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Improvement of NRS score within 2 hrs after administration [ Time Frame: Pre-administration, 30, 60, 90 and 120 minutes post-administration ]
Average change (slope) of NRS score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • 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
  • Time to event [ Time Frame: 2 hours after initial administration to Day 7 ]
    Time to event analysis of analgesic effect
  • 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
  • Rescue medication use [ Time Frame: Day 1 to Day 13 ]
    Number of times of rescue medication use
  • Effective concentration [ Time Frame: Day 0 to Day 13 ]
    Blood phenytoin concentration
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • 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
  • Time to event [ Time Frame: 2 hrs after initial administration to Day 7 ]
    Time to event analysis of analgesic effect
  • 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 compared to baseline
  • Rescue medication use [ Time Frame: Day 1 to Day 13 ]
    Number of times of rescue medication use
  • Effective concentration [ Time Frame: Day 0 to Day 13 ]
    Blood phenytoin concentration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Clinical Trial of NPC-06 in Patients With Neuropathic Pain in Cancer
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain in Cancer
Intervention  ICMJE Drug: NPC-06
Patients will receive once a day for 7 days.
Study Arms  ICMJE
  • 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
    Intervention: Drug: NPC-06
  • 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
    Intervention: Drug: NPC-06
  • Placebo Comparator: Placebo
    Saline will be administered intravenously
    Intervention: Drug: NPC-06
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 12, 2020)
7
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
40
Actual Study Completion Date  ICMJE September 30, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773055
Other Study ID Numbers  ICMJE NPC-06-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nobelpharma
Study Sponsor  ICMJE Nobelpharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nobelpharma
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP