DDrare: Database of Drug Development for Rare Diseases

70. 広範脊柱管狭窄症
［臨床試験数：91，薬物数：195（DrugBank：54），標的遺伝子数：60，標的パスウェイ数：85］

Searched query = "Spinal stenosis", "Extensive spinal canal stenosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.5% marcaine; 0.9% Saline; 0002-8971; 1mg/kg/hr TXA intravenous infusion till the last suture; AK1320 MS; Acetaminophen; Acetate; Adjunctive analgesics; Adjunctive anti-depressants; AlloGen-LI; Alprostadil; Amino acids; Aminocaproic acid; Amniotic Fluid Allograft; Apple; Bilateral transforaminal epidural steroid injections; Bone Marrow Concentrate; Botulinum toxin type A; Botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle; Bupivacaine; Bupivacaïne HCl 0,125% / Sufentanil 50 µg flacon à 50 ml; Buprenorphine; CO; Caudal Epidural Injection with Celestone; Caudal Epidural Injection with DepoMedrol; Caudal Epidural Injection with generic Celestone; Caudal epidural injection; Celebrex 200Mg Capsule; Celecoxib; Cilostazol; Combination Product: Goldic serum; Control group; Creatinine; DEXMEDETOMIDINE; DEXMEDETOMIDINE HYDROCHLORIDE; Darvocet; Decadron Phosphate, Injectable; Deksmedetomidiini; Demineralized Bone Matrix; DepoMedrol; Depomedrol; Device: Apple Watch and App; Device: Bioactive Glass-Ceramic Spacer; Device: Cervical Orthosis (CO); Device: Interbody cage (PEEK); Device: Interbody cage (titanium); Device: MILD® (Minimally Invasive Lumbar Decompression); Device: MRI; Device: MasterGraft Granules; Device: No Orthosis; Device: Philips Intelivue MP70 monitor; Device: Pleth Variability Index (PVI); Device: Therm-AppTM TH, thermographic camera; Device: Titanium cage; Dexamethasone; Dexamethasone sodium phosphate; Dexdor; Dexmedetomidine; Dexmedetomidine group; Dexmedetomidine with ropivacaine; Dextrose; Diphenhydramine; EACA; ESKETAMINE HYDROCHLORIDE; Epidural Steroid Injection; Epidural injection; Epidural local anesthetic injection; Epidural steroid injection; Epsilon-Aminocaproic Acid (EACA); Erector spinae plane block (Group E); Erythropoietin; Esketamine; Fentanyl; Forsteo; Forteo; Gabapentin; Heparin; Herbal medicine; Hyaluronic Acid; Hyaluronic acid; Hydromorphone; I-FACTOR; KETAMINE; Kenalog Injectable Product; Ketamine; Ketanest; Ketanest-S; Ketorolac; Limaprost; Liposomal bupivacaine; Lumbar Interbody Fusion with Autograft; Lumbar Interbody Fusion with NeoFuse; MONITOR; Magnesium; Magnesium with ropivacaine; Midazolam; Mirogabalin; Misoprostol; Modal; Modified-thoracolumbar interfascial plane block; Morphine; Morphine PCA; Multi-modal pain management [Acetaminophen + Gabapentin]; Multi-modal pain management [Fentanyl]; Multi-modal pain management [Intravenous Ketamine]; Multi-modal pain management [Valium + Gabapentin]; NS-304; NS-304 Placebo; NSAIDs; NeoFuse; Nicardipine; Normal saline; NuCel; OXYCODONE; OXYCODONE HYDROCHLORIDE; Oksikodoni; Opana; Other: Control; Other: Conventional PCA mode; Other: Epiduroscopy; Other: Group Exercise: community setting; Other: Individualized exercises: clinical setting; Other: Joint Mobilizations (spine, sacroiliac, hip); Other: Optimizing basal infusion (B.I); Other: Other intervention(s); Other: no intervention; Other: physical therapy; Oxanest; Oxycodone; Oxycodone Orion; Oxygen; PCA; PLF with NeoFuse; Parathyroid hormone; Phosphate; Polydeoxyribonucleotides; Predinose oral; Pregabalin; Pregabalin 75mg; Procedure: Acupuncture; Procedure: Allograft; Procedure: Bee venom pharmacopuncture; Procedure: Chuna manipulation; Procedure: Chuna manual medicine; Procedure: Cupping; Procedure: Electroacupuncture; Procedure: Epidural Steroid Injection; Procedure: Epidural local anesthetic injection; Procedure: Epidural steroid with local anesthetic injection; Procedure: Lumbar epidural injection; Procedure: MILD Procedure; Procedure: Manual therapy; Procedure: Other intervention(s); Procedure: PLF with autograft; Procedure: Percutaneous Lumbar Decompression; Procedure: Pharmacopuncture; Procedure: epidural steroid (dexamethasone) injection; Procedure: lumbar interlaminar epidural steroid injection; Procedure: posterolateral spinal fusion with instrumentation; Prolotherapy solution of 20% dextrose; Remifentanil; RhPTH; RhPTH (1-34); Ropivacaine; Ropivacaine plus normal saline; S-ketamine; S-ketamine & midazolam; Selexipag; Standard analgesia use [Fentanyl]; Standard analgesia use [Hydromorphone]; Standard analgesia use [Oxygen]; Standard analgesia use [Volatile Anesthesia]; Steroid injections; Sufentanil; Sugar Pill; Teicoplanin; Teriparatide; Teriparatide [rDNA origin] contains recombinant human parathyroid hormone (1-34); Titanium; Tramadol; Tramadol with ropivacaine; Tranexamic Acid; Tranexamic Acid 100 MG/ML; Tranexamic acid; Transdermal fentanyl matrix, gabapentin; Transforaminal Epidural Injection; Triamcinolone; Triamcinolone Acetonide and normal saline solution; Tylenol; Vancomycin; ViviGen Cellular Bone Matrix; With U-VANCO (vancomycin hydrochloride); Without U-VANCO (vancomycin hydrochloride); Wound topically irrigated with 500mg TXA; Xylocaine

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 Spiral Stenosis	Comparison in the effect and safety of Mirogabalin add-on therapy to NSAIDs and NSAIDs monotherapy for patients with Lumber Spiral 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	Daiichi Sankyo Co., Ltd	Recruiting	>= 20age old	Not applicable	Both	300	N/A	Japan

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

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 Spiral Stenosis

Comparison in the effect and safety of Mirogabalin add-on therapy to NSAIDs and NSAIDs monotherapy for patients with Lumber Spiral 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

Daiichi Sankyo Co., Ltd

Recruiting

>= 20age old

Not applicable

Both

300

N/A

Japan