The Effectiveness of mirogabalin on peripheral neuropathy among patients treated with oxaliplatin

JRCT ID: jRCT1041210094

Registered date:01/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peripheralneuropathicpain
• Date of first enrollment: 01/11/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Administer mirogabalin for 42 days.

Outcome(s)

• Primary Outcome: Tingling 30% improvement rate
• Secondary Outcome: Change in NRS for Tingling, Numbness, and Pain from baseline

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who received oxaliplatin for the treatment of colorectal cancer, and tingling scores of 4 or more on the NRS scale in the hands or feet at the time of enrollment.
• Exclude criteria: Patients with peripheral neuropathy caused by other diseases at the time of registration, with concomitant diabetes mellitus for whom neuropathy is a concern at the time of enrollment, and patients who have started, discontinued, or had a dose change of 10% or more of duloxetine, acetaminophen, NSAIDs, high-dose aspirin, or opioids within 14 days of enrollment.

Related Information

• Primary Sponsor: Watanabe Daichi