Special drug-use survey of Tarlige tablet (evaluation of safety in patients with impaired renal function)
- Conditions
- Peripheral neuropathic pain
- Registration Number
- JPRN-jRCT1080224834
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
There was no difference in the risk of dizziness- or somnolence-related events between the normal/mild group and the moderate/severe group. However, the incidence of dizziness- and somnolence-related events was higher in patients with end-stage renal failure/requiring hemodialysis. Our findings suggest that patients with end-stage renal failure or requiring hemodialysis should be carefully monitored and the dose of mirogabalin adjusted according to package insert.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 2021
1.Patients with peripheral neuropathic pain not treated with Tarlige tablet before
2.Patients with creatinine clearance (using the Cockcroft-Gault equation, pre-dialysis values for dialysis patients) within 12 months before starting administration of Tarlige tablet, and for whom the degree of impaired renal function can be confirmed
3.Patients who started administration of Tarlige tablet during the contract period (contract period based on the contract with each medical site)
4.Patients who started administration of Tarlige tablet during the registration period
5.Patients from whom written informed consent was obtained
Patients who do not meet eligibility criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Incidence of adverse drug reaction with dizziness<br>Incidence of adverse drug reaction with somnolence
- Secondary Outcome Measures
Name Time Method safety<br>Incidence of adverse drug reaction leading to treatment discontinuation