cancer pain
Conditions
Interventions
investigational material(s)
Generic name etc : NZ-687 sustainted release tablet
INN of investigational material : -
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agent
Sponsors
Nippon Zoki Pharmaceutical Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have cancer pain without opioid treatment 2) Patients who have been informed of their type of cancer that have been diagnosed. 3) Patients that the principal investigator or subinvestigator expects survival to be at least 3 months from the start date of the study drug administration. 4) Patients who are on nonopioid analgesic therapies (NSAIDs or acetaminophen) and have never received opioid analgesics, and need tramadol administration. 5) Patients with a mean pain level at rest (VAS measurement) of 25 mm or above on two days and one day before the start of the study drug administration, and the day of the start of the study drug administration.
Exclusion criteria
Exclusion criteria: 1) Patients with symptoms associated with brain tumor or brain metastasis. 2) Patients with symptoms of brain disorder, cerebral infarction, or brain hemorrhage, or having had those symptoms within 6 months from the day of signing the informed consent form. 3) Patients with convulsive and/or epileptic seizure, or having a medical history of them. 4) Patients with serious respiratory, heart, kidney, liver, or hematologic diseases (excluding cancer) 5) Patients with other types of pain that affect the efficacy evaluation. 6) Patients who underwent procedures including surgical operation, radiation therapy, nerve block or stimulation-produced analgesia, which would affect the evaluation, within 7 days before the start of the of the study drug administration, or are scheduled to undergo such procedures during the study period (except the follow-up period). 7) Patients for whom the principal investigator or subinvestigator considers that continuation of chemotherapy that had been started before the time of signing informed consent form would make evaluation of efficacy and safety of the study drug difficult, or who are scheduled to change chemotherapy during the study period (except the follow-up period) and who are scheduled to start a new chemotherapy during the study period (except the follow-up period). 8) Women who are pregnant, breast-feeding, and suspected of being pregnant, or who hope to be pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy the change in VAS pain score at rest from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy the change in VAS pain score at movement from baseline, number of rescue dose, time of persistent pain, nocturnal sleep, QOL score(EQ-5D-5L) | — |
Countries
Japan
Outcome results
None listed