70. 広範脊柱管狭窄症 Spinal stenosis Clinical trials / Disease details
臨床試験数 : 95 / 薬物数 : 169 - (DrugBank : 61) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 90
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCTs021200007 | 19/06/2020 | 03/06/2020 | MiroTAS | Efficacy and Safety of Mirogabalin for the Treatment as Add-On to NSAIDs in patients with Peripheral Neuropathic Pain caused by Lumbar Spinal Stenosis : Multi-institutional, randomized, open, parallel-design and interventional Study | Lumber Spinal Stenosis | Comparison in the effect and safety of Mirogabalin add-on therapy to NSAIDs and NSAIDs monotherapy for patients with Lumber Spinal Stenosis and administrated of NSAIDs. 1) NSAIDs monotherapy as a study drug are prescribed in accordance with a package insert and each of their administration and dosage is not changed while a study drug is administrated. 2) Mirogabalin add-on therapy to NSAIDs: NSAIDs as a study drug are prescribed in accordance with a package insert and each of their administration and dosage is not changed while a study drug is administrated. Mirogabalin is prescribed as follows in accordance with renal function of a subject. Patients with creatinine clearance more than 60mL/min: Mirogabalin is administrated in dose of 5mg twice a day at the first week. At the next week, Mirogabalin is administrated in dose of 10mg twice a day. At week 5(after Visit3), dose of Milogabalin is increased to 15mg twice a day unless there is no problem with the safety. After that, the dose of Mirogabalin is controlled by 10mg twice a day or 15mg twice a day depending on safety findings. Patients with creatinine clearance 30-60mL/min: Mirogabalin is administrated in dose of 2.5mg twice a day at the first week. At the next week, Mirogabalin is administrated in dose of 5mg twice a day. At week 5(after Visit3), dose of Milogabalin is increased to 7.5mg twice a day unless there is no problem with the safety. After that, the dose of Mirogabalin is controlled by 5mg twice a day or 7.5mg twice a day depending on safety findings. Also, more than 7 days washout period before enrollment is required for target patients administrated of prohibited drugs. If the administration of Mirogabalin is discontinued, down-titration is needed in accordance with the insert package. | Nikaido Takuya | NULL | Complete | >= 20age old | Not applicable | Both | 300 | N/A | Japan |