Special drug-use survey of Tarlige (evaluation of the efficacy in patients with peripheral neuropathic pain)
- Conditions
- Peripheral neuropathic pain
- Registration Number
- JPRN-jRCT1080224913
- Lead Sponsor
- DAIICHI SANKYO CO., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1890
1.Patients with peripheral neuropathic pain not treated with Tarlige tablet before
2.Patients with 12 or more points in the neuropathic pain screening questionnaire
3.Patients with pain lasting more than 3 months
4.Patients with a pain scale of 40 mm or more on VAS before administration of Tarlige tablet
5.Patients who started administration of Tarlige tablet during the contract period (contract period based on the contract with each medical site)
6.Patients who started administration of Tarlige tablet during the registration period
7.Patients from whom written informed consent was obtained
1.Patients with a pain scale of 90 mm or less on VAS before administration of Tarlige tablet
2.Patients with other pain unrelated to PNP, that may confound the assessment of PNP
3.Patients with Neurologic disorders (depression, bipolar disorder, schizophrenia, etc.)
4.Patients with dementia, etc. who cannot respond appropriately to questionnaires and VAS for pain
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The 50% responder rate of VAS for pain
- Secondary Outcome Measures
Name Time Method efficacy<br>1)The 30% responder rate of VAS for pain<br>2)SF-8 score change from baseline for each domain<br>3)The 50% responder rate of VAS for sleep-interference<br>4)The 30% responder rate of VAS for sleep-interference<br>5)Ratio of 'very much improved' or 'much improved' in PGIC<br>6)Ratio of 'very much improved', 'much improved' or 'minimally improved' in PGIC