MIROP Study

Not Applicable

• Conditions: Peripheral Neuropathic Pain

• Registration Number: JPRN-jRCTs031190113
• Lead Sponsor: Kimura Yoshiyuki

Brief Summary

Mirogabalin switching from pregabalin is generally well tolerated and effective in pain management for peripheral neuropathic pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-08
• Study Completion: 2020-04-22
• Results First Posted: 2021-04-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1) Patients diagnosed with Peripheral Neuropathic Pain.
2) Patients who is administrated Pregabalin for more than 28 days at enrollment of the study.
3) Patients with more than 40mm of VAS at informed consent and enrollment.
4)Patients with 20 years old or older at enrollment.
5)Patients who give their voluntary Written consent to participate in the study, also patients who are able to understand the procedure of the clinical study and answer a question appropriately.

Exclusion Criteria

1) Patients who have past history of hypersensitivity to ingredients of Mirogabalin and Pregabalin.
2) Patients who have difficuly participating in the study due to severe complication of Liver Disease, Kidney Disease and Heart Disease.
3) Patients with creatinine clearance less than 30mL/min by Cockroft-Gault Equation at enrollment.
4) Pregnancy patients or patients who have possibility of pregnancy.
5) Nursing mothers.
6) Patients who are inappropriate for participation in the study for other reason in the opinion of the investigator or sub-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of occurrence of Somnolence, Dizziness and Peripheral edema from the enrollment to the end of the study

Secondary Outcome Measures

Name	Time	Method
Amount of the change of pain intensity(VAS) from the enrollment to the end of the study