JPRN-jRCTs051190097
Recruiting
Phase 3
International, multi-centre, double-blind, dose increment, parallel-arm, randomised controlled of duloxetine versus pregabalin over 14 days for opioid unresponsive cancer-related neuropathic pain
Matsuoka Hiromichi0 sites160 target enrollmentJanuary 27, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Matsuoka Hiromichi
- Enrollment
- 160
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inpatients and outpatients with diagnoses of cancer and neuropathic pain
- •Age 18 years or more
- •KPS 27 or AKPS 28 50 or greater
- •Able to complete study assessments and complying with the study procedures
- •Ability to provide informed written consent
- •Pain related to cancer with a worst pain score of 4 or greater on BPI item 3 (worst pain intensity) score in the past 24 hours
- •Neuropathic Pain on LANSS 12 or greater
- •An adequate opioid medication which is defined as titration to the maximum tolerated dose or titration to at least a dose of 60mg/day oral morphine equivalent dose for 24 hours unless otherwise contra\-indicated
- •Stable regular analgesics (opioids, paracetamol, non\-steroidal anti\-inflammatory drugs) and any type of regular adjuvant analgesics (e.g. antidepressants, anticonvulsants, antiarrhythmic agents, N\-methyl\-D\-aspartate receptor antagonists, and steroids) as an analgesic in the 72 hours before commencing the study.
Exclusion Criteria
- •Chemotherapy\-Induced Peripheral Neuropathy (glove and stocking)
- •Spinal cord compression
- •Contraindication for duloxetine or pregabalin
- •Taking gabapentioids or duloxetine for any reason within 2 weeks.
- •Taking SSRI or SNRI for any reason.
- •Participants who have participated in a clinical study of a new chemical entity within the four weeks prior to study entry
- •Patients with clinically significant cognitive impairment (clinician defined) causing unreliable completion of study procedures
- •Patients who have a recent history of drug misuse.
- •Patients who are pregnant, breastfeeding or may possibly be pregnant
- •Other patients who are determined to be inappropriate for participation in the study by the clinical investigator.
Outcomes
Primary Outcomes
Not specified
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