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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

NCT06711978 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-12-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Pusan National University Yangsan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-05-31
Completion
2025-06-30

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06711978 on ClinicalTrials.gov