SI-6603 (Condoliase) -studie för ländryggsskivherniering (Discovery 6603-studie)

En multicenter, slumpmässig, dubbelblind, skamstyrd, Kommentande studie av SI-6603 hos ämnen med ländryggsherniering (fas 3)

Sponsorer

Ledande sponsor: Seikagaku Corporation

Källa Seikagaku Corporation
Kort sammanfattning

Denna studie är att utvärdera effektiviteten av en engångsinjektion av intervertebral skiva av SI-6603 hos patienter med ländryggsbråck (LDH)

Övergripande status Rekrytering
Start datum 2018-05-30
Slutförelsedatum 2022-11-01
Primärt slutdatum 2022-02-01
Fas Fas 3
Studietyp Interventionell
Primärt resultat
Mäta Tidsram
Genomsnittlig värsta värk i benvärk under de senaste 24 timmarna under de senaste sju dagarna Mediterraans diëet
Sekundärt resultat
Mäta Tidsram
Average worst leg pain score during the past 24 hours over the previous 7 days 52 weeks
Hernieringsvolym bedömd av MR Mediterraans diëet
Oswestry Disability Index (ODI) -poäng Mediterraans diëet
Inskrivning 320
Tillstånd
Intervention

Interventionstyp: Drug

Interventionens namn: SI-6603

Beskrivning: SI-6603 will be injected into an intervertebral disc.

Arm Group-etikett: SI-6603

Interventionstyp: Läkemedel

Interventionens namn: Skaminsprutning

Beskrivning: Injektionen kommer att utföras utan att nålen placeras i en intervertebral skiva.

Arm Group-etikett: Skaminsprutning

Behörighet

Kriterier:

Inklusionskriterier: - Ämnen med ennivå LDH (L4-L5 eller L5-S1 (eller L5-L6)) med tydlig, påvisbar nervrotpåverkan enligt magnetisk resonanstomografi (MR) och klinisk symtom som motsvarar den nedsatta nervrotens position. - Ämnen med radikulopati / radikulär benvärk i det ensidiga benet i 6 veckor eller mer än 1 år eller mindre. - Ämnen med positivt resultat av Straight Leg Raise (SLR) test (≤70 °) endast på ipsilateralt ben med huvudklagomål om radikulopati - Ämnen med otillräcklig förbättring av smärta orsakad av LDH trots 6 veckor eller mer av konservativ behandling. Exklusions kriterier: - Ämnen som har 2 eller fler ländryggsbråck som bedömts av MR. - Ämnen som har genomgått en ländryggsoperation, ländryggens perkutana nukleotomi eller ländryggens intradiskala terapier vid den drabbade nivån av ländryggen. - Ämnen som har fått blockprocedur (t.ex. ryggradsinjektion, epidural injektion eller nervblockering) för behandling av LDH, orala eller injicerbara kortikosteroider inom 28 dagar före randomisering. - Ämnen som har fått opioider eller cannabis via någon administreringsväg, lokal anestesi mot ryggen, skinkan eller bakre / laterala aspekterna av det drabbade benet inom 7 dagar före randomisering. - Ämnen med ett kroppsmassindex (BMI) ≥40. - Ämnen som får ersättning enligt lagen om arbetskraftsersättning eller är involverade i personskadestrid på grund av en ländryggsskada.

Kön:

Allt

Lägsta ålder:

Mediterraans diëet

Högsta ålder:

70 år

Friska volontärer:

Nej

Övergripande kontakt

Efternamn: Kyoichi Osano (for overall study)

Telefon: +81-3-5220-8948

E-post: [email protected]

Plats
Anläggning: Status:
Delta Clinical Research | Mobile, Alabama, 36609, United States Recruiting
Shoals Medical Trials, Inc. | Sheffield, Alabama, 35660, United States Recruiting
HOPE Research Institute | Peoria, Arizona, 85381, United States Withdrawn
HOPE Research Institute | Phoenix, Arizona, 85018, United States Withdrawn
Coastal Pain and Spinal Diagnostics | Carlsbad, California, 92009, United States Recruiting
Pain Medicine Associates, Inc. | Fountain Valley, California, 92708, United States Recruiting
Allied Clinical Research | Gold River, California, 95670, United States Withdrawn
University of California San Diego - Center for Pain Medicine | La Jolla, California, 92093, United States Recruiting
The Helm Center for Pain Management | Laguna Woods, California, 92637, United States Recruiting
The Anand Spine Group | Los Angeles, California, 90048, United States Terminated
VA Greater Los Angeles Healthcare System | Los Angeles, California, 90073, United States Recruiting
Samaritan Center for Medical Research | Los Gatos, California, 95032, United States Recruiting
Neurovations Research | Napa, California, 94558, United States Recruiting
Restore Othropedics and Spine Center | Orange, California, 92868, United States Withdrawn
UC Davis Spine Center | Sacramento, California, 95816, United States Recruiting
St. Mary's Medical Center | San Francisco, California, 94117, United States Withdrawn
Source Healthcare | Santa Monica, California, 90403, United States Recruiting
Boulder Neurosurgical Associates | Boulder, Colorado, 80303, United States Recruiting
DBPS Research, LLC | Greenwood Village, Colorado, 80111, United States Recruiting
International Spine, Pain, and Performance Center | Washington, District of Columbia, 20006, United States Recruiting
Florida Spine Institute | Clearwater, Florida, 33765, United States Recruiting
South Lake Pain Institute | Clermont, Florida, 34711, United States Withdrawn
Spine and Orthopedic Center | Deerfield Beach, Florida, 33441, United States Not yet recruiting
Deland Clinical research Unit | DeLand, Florida, 32720, United States Recruiting
Science Connections, LLC | Doral, Florida, 33166, United States Recruiting
Coastal Clinical Research | Fernandina Beach, Florida, 32034, United States Recruiting
Holy Cross Medical Group | Fort Lauderdale, Florida, 33334, United States Recruiting
Jacksonville Center for Clinical Research - Inpatient Team | Jacksonville, Florida, 32216, United States Withdrawn
Coastal Clinical Research | Jacksonville, Florida, 32224, United States Recruiting
The B.A.C.K. Center | Melbourne, Florida, 32901, United States Withdrawn
AMPM Research Clinic | Miami Gardens, Florida, 33169, United States Recruiting
Genoma Research Group, Inc. | Miami, Florida, 33155, United States Recruiting
Pharma Research International, Inc. | Naples, Florida, 34102, United States Withdrawn
Orthopaedic Center of South Florida | Plantation, Florida, 33324, United States Withdrawn
Florida Medical Pain Management | Saint Petersburg, Florida, 33709, United States Withdrawn
Pain Relief Centers | Saint Petersburg, Florida, 33709, United States Recruiting
South Florida Clinical Research, LLC | South Miami, Florida, 33143, United States Withdrawn
Pain Relief Centers | Sun City Center, Florida, 33573, United States Recruiting
Tampa Pain Relief Center | Tampa, Florida, 33603, United States Recruiting
Florida Pain Relief Group, PLLC | Tampa, Florida, 33614, United States Recruiting
Premier Medical Associates | The Villages, Florida, 32159, United States Recruiting
Conquest Research | Winter Park, Florida, 32789, United States Recruiting
National Pain Research Institute, LLC | Winter Park, Florida, 32789, United States Withdrawn
Augusta University - Medical College of Georgia | Augusta, Georgia, 30912, United States Recruiting
Non-Surgical Orthopaedics, P.C | Marietta, Georgia, 30060, United States Recruiting
Injury Care Research | Boise, Idaho, 83713, United States Recruiting
Millennium Pain Center | Bloomington, Illinois, 61704, United States Recruiting
Chicago Anesthesia Pain Specialists | Chicago, Illinois, 60657, United States Recruiting
Indiana Spine Group | Carmel, Indiana, 46032, United States Recruiting
Mid America PolyClinic - Pain Med | Overland Park, Kansas, 66210, United States Withdrawn
Neuroscience Research Center LLC | Overland Park, Kansas, 66210, United States Recruiting
OtriMed Clinical Research | Edgewood, Kentucky, 41017, United States Recruiting
Clinical Trials of Southwest Louisiana, LLC | Lake Charles, Louisiana, 70601, United States Recruiting
Tulane University School of Medicine | New Orleans, Louisiana, 70112, United States Recruiting
Orthopaedic Associates of Michigan | Grand Rapids, Michigan, 49525, United States Recruiting
Michigan Orthopaedic and Spine Surgeons | Rochester Hills, Michigan, 48307, United States Withdrawn
St. Louis Pain Consultants | Chesterfield, Missouri, 63017, United States Recruiting
Comprehensive and Interventional Pain Management LLP | Henderson, Nevada, 89052, United States Terminated
Innovative Pain Care Center | Las Vegas, Nevada, 89106, United States Recruiting
Interventional Spine Medicine | Barrington, New Hampshire, 03825, United States Recruiting
New Jersey Regenerative Institute | Cedar Knolls, New Jersey, 07927, United States Recruiting
Rothman Institute | Egg Harbor Township, New Jersey, 08234, United States Withdrawn
New York - Presbyterian Queens | Flushing, New York, 11355, United States Recruiting
New York Orthopaedic & Spine Center | Great Neck, New York, 11021, United States Withdrawn
Drug Trials America | Hartsdale, New York, 10530, United States Recruiting
Ainsworth Institute Of Pain Management | New York, New York, 10022, United States Recruiting
University of Rochester- Neuromedicine Pain Management Center | Rochester, New York, 14618, United States Recruiting
The Center for Clinical Research | Winston-Salem, North Carolina, 27103, United States Recruiting
Clinical Inquest Center Ltd | Beavercreek, Ohio, 45431, United States Recruiting
The Ohio State University Wexner Medical Center | Columbus, Ohio, 43210, United States Recruiting
META Medical Research Institute | Dayton, Ohio, 45432, United States Recruiting
Medical Research International | Oklahoma City, Oklahoma, 73109, United States Recruiting
Oklahoma City Clinical Research Center | Oklahoma City, Oklahoma, 73159, United States Recruiting
Center for Interventional Pain and Spine | Exton, Pennsylvania, 19341, United States Not yet recruiting
Main Line Spine | King Of Prussia, Pennsylvania, 19406, United States Recruiting
Clinical Trials of South Carolina | Charleston, South Carolina, 29406, United States Recruiting
Carolinas Center For Advanced Management Of Pain | Greenville, South Carolina, 29615, United States Withdrawn
SC Pain & Spine Specialists | Murrells Inlet, South Carolina, 29576, United States Recruiting
Coastal Carolina Research Center | North Charleston, South Carolina, 29403, United States Withdrawn
Ascension Spine and Scoliosis Center | Austin, Texas, 78731, United States Recruiting
First Surgical Hospital | Bellaire, Texas, 77401, United States Withdrawn
HRMD Research | Dallas, Texas, 75240, United States Recruiting
Advanced Medical Trials | Georgetown, Texas, 78628, United States Recruiting
Interventional Pain Specialists | Pasadena, Texas, 77505, United States Not yet recruiting
ARH Research, LLC. | The Woodlands, Texas, 77382, United States Recruiting
The Smart Clinic | Draper, Utah, 84020, United States Withdrawn
JBR Clinical Research | Salt Lake City, Utah, 84107, United States Recruiting
University of Virginia Orthopaedic Spine Center | Charlottesville, Virginia, 22903, United States Recruiting
Virginia iSpine Physicians, P.C. | Richmond, Virginia, 23235, United States Recruiting
Gershon Pain Specialists | Virginia Beach, Virginia, 23454, United States Recruiting
Swedish Pain Management | Seattle, Washington, 98122, United States Recruiting
West Virginia University | Morgantown, West Virginia, 26506, United States Recruiting
Platsländer

United States

Verifieringsdatum

2021-07-01

Ansvarig part

Typ: Sponsor

Nyckelord
Har utökad åtkomst Nej
Antal vapen 2
Arm Group

Märka: SI-6603

Typ: Experimental

Märka: Skaminsprutning

Typ: Skamkomparator

Information om studiedesign

Tilldelning: Slumpmässigt

Interventionsmodell: Parallell uppgift

Huvudsakliga syfte: Behandling

Maskering: Fyrdubbel (deltagare, vårdgivare, utredare, resultatbedömare)

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