NCT06711978

Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN). There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN). Participants will: * Take drug duloxetine or a mirogabalin every day for 4 weeks. * Visit the clinic once every 2 weeks for checkups and tests

Conditions

• CIPN
• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• CIPN in Adjuvant Breast Cancer Patients
• Duloxetine
• Mirogabalin

Interventions

Type	Name	Description
DRUG	Mirogabalin	Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.
DRUG	Duloxetine	Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-05-31
• Completion: 2025-06-30
• First posted: 2024-12-02
• Last updated: 2024-12-02

Locations

1 site across 1 country: South Korea