Efficacy of duloxetine for cancer patients with neuropathic pain: Doubleblind, Randomized, Placebo controlled, exploratory trial

Not Applicable

• Conditions: Cancer Pain

• Registration Number: JPRN-UMIN000017647
• Lead Sponsor: Japan Agency for Medical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1) Chemotherapy-induced Peripheral Neuropathy 2) Progressive paralysis 3) Allergy to duloxetine 4) Depression 5) Patients who changed analgesic adjuvant agents within 2 days 6) Drug dependence or abuse 7) Uncontrolled psychiatric disease 8) Pregnancy or lactating patients 9) Patients who are judged as inadequate to participate to the trial due to other reasons by the doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain NRS (BPI-item4, 24-hour average intensity of global pain)on Day10

Secondary Outcome Measures

Name	Time	Method
Hospital anxiety and depression scale, Short-Form Mcgill Pain Questionnaire 2, European Organization for Research and Treatment of Cancer Quority of Life Questionnaire Core 15 palliative, Pain Catastrophizing Scale, Adverse Events, Rescue dose, Pain NRS on Day10 by subgroups (nonresponsive or intolerant to gabapentinoids)