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Special drug-use survey of Tarlige (evaluation of the efficacy in patients with peripheral neuropathic pain)

Special drug-use survey of Tarlige (evaluation of the efficacy in patients with peripheral neuropathic pain)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1080224913
Enrollment
1890
Registered
2019-10-15
Start date
2019-10-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral neuropathic pain

Interventions

none

Sponsors

DAIICHI SANKYO CO., LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
efficacy The 50% responder rate of VAS for pain

Secondary

MeasureTime frame
efficacy 1)The 30% responder rate of VAS for pain 2)SF-8 score change from baseline for each domain 3)The 50% responder rate of VAS for sleep-interference 4)The 30% responder rate of VAS for sleep-interference 5)Ratio of 'very much improved' or 'much improved' in PGIC 6)Ratio of 'very much improved', 'much improved' or 'minimally improved' in PGIC

Countries

Japan

Contacts

Public ContactGPSP Contact

GPSP for Contact

contact_gpsp@daiichisankyo.co.jp+81-362251059

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026