臨床研究等提出・公開システム

A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of DS-1971a in patients with pain caused by radiculopathy due to lumbar spinal stenosis

DS-1971a Phase 2 study

DAIICHI SANKYO Co.,Ltd.

http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html

Interventional

A double-blind study

2

-Subjects who are able to understand the study procedures, complete the electronic patient diary and electronic patient questionnaire, and appropriately answer the physician's questions.

-Subjects who have lower limb pain caused by radiculopathy that has been persisting for at least 3 months before the start day of the screening period and that can be explained by lumbar spinal stenosis found by magnetic resonance imaging (MRI).

-Subjects who have undergone any lumbar surgery or require any lumbar surgery during the study period.

-Subjects who have any disease that may affect the evaluation of pain of lower limbs (ASO, rheumatoid arthritis, diabetic peripheral neuropathy, etc.).

-Subjects who have undergone any brain or spinal cord surgery or require any brain or spinal cord surgery during the study period

-Subjects who have central neuropathic pain

Both

Pain caused by radiculopathy due to lumbar spinal stenosis

investigational material(s)
Generic name etc : DS-1971a
INN of investigational material :
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agents
Dosage and Administration for Investigational material : oral administration(200 mg/day, 800 mg/day, and 1200 mg/day)

control material(s)
Generic name etc : placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : oral administration

Average daily pain score
To compare the change from baseline in the weekly average daily pain score at end of treatment of DS-1971a to that for placebo.

HADS , SF-36
To compare the change from baseline in the HADS and SF-36 at end of treatment of DS-1971a to that for placebo.