Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
NCT ID: NCT03372161
Last Updated: 2022-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
401 participants
INTERVENTIONAL
2017-12-08
2022-01-06
Brief Summary
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The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SP-102
SP-102
SP-102
injection
Placebo
Placebo
Placebo
injection
Interventions
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SP-102
injection
Placebo
injection
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 70 years (inclusive) at the Screening Visit.
* A diagnosis of lumbosacral radicular pain (sciatica).
* Agrees to follow study-specific medication requirements.
* If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
* Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.
Exclusion Criteria
* Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
* Has been diagnosed with insulin dependent diabetes mellitus.
* Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
* Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
* Has a body mass index ≥40 kg/m2.
18 Years
70 Years
ALL
No
Sponsors
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Worldwide Clinical Trials
OTHER
Semnur Pharmaceuticals, Inc.
INDUSTRY
Scilex Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dmitri Lissin, MD
Role: STUDY_DIRECTOR
Scilex Pharmaceuticals, Inc.
Locations
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Semnur Research Site 75
Mobile, Alabama, United States
Semnur Research Site 52
Phoenix, Arizona, United States
Semnur Research Site 58
Tempe, Arizona, United States
Semnur Research Site 18
La Jolla, California, United States
Semnur Research Site 47
Laguna Woods, California, United States
Semnur Research Site 70
Los Gatos, California, United States
Semnur Research Site 56
Fernandina Beach, Florida, United States
Semnur Research Site 81
Jacksonville, Florida, United States
Semnur Research Site 49
St. Petersburg, Florida, United States
Semnur Research Site 13
Tampa, Florida, United States
Semnur Research Site 61
Tampa, Florida, United States
Semnur Research Site 53
Winter Park, Florida, United States
Semnur Research Site 28
Marietta, Georgia, United States
Semnur Research Site 64
Marietta, Georgia, United States
Semnur Research Site 10
Newnan, Georgia, United States
Semnur Research Site 38
Boise, Idaho, United States
Semnur Research Site 40
Bloomington, Illinois, United States
Semnur Research Site 63
Chicago, Illinois, United States
Semnur Research Site 12
Chicago, Illinois, United States
Semnur Research Site 19
Chicago, Illinois, United States
Semnur Reseach Site 62
Overland Park, Kansas, United States
Semnur Research Site 51
Burlington, Massachusetts, United States
Semnur Research Site 65
Omaha, Nebraska, United States
Semnur Research Site 60
Las Vegas, Nevada, United States
Semnur Research Site 30
Shrewsbury, New Jersey, United States
Semnur Research Site 11
Durham, North Carolina, United States
Semnur Research Site 20
Winston-Salem, North Carolina, United States
Semnur Research Site 46
Cleveland, Ohio, United States
Semnur Research Site 43
Cuyahoga Falls, Ohio, United States
Semnur Research Site 36
Oklahoma City, Oklahoma, United States
Semnur Research Site 48
Charleston, South Carolina, United States
Semnur Research Site 77
Greenville, South Carolina, United States
Semnur Research Site 15
Houston, Texas, United States
Semnur Research Site 54
Plano, Texas, United States
Semnur Research Site 35
Tyler, Texas, United States
Semnur Research Site 59
Draper, Utah, United States
Semnur Research Site 42
Greenfield, Wisconsin, United States
Countries
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References
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Miller A, Candido KD, Knezevic NN, Rivera J, Lunseth P, Levinson DJ, Formoso F, Solanki D, Tavel E, Krull A, Radnovich R, Burkhead D, Souza D, Helm S, Katz N, Dworkin RH, Cohen SP, Rathmell JP, Buvanendran A, Levin J, Stannard E, Ambrose C, Jaros M, Vought K, Lissin D. A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain. Pain. 2024 Dec 1;165(12):2762-2773. doi: 10.1097/j.pain.0000000000003287. Epub 2024 Jun 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SP-102-02
Identifier Type: -
Identifier Source: org_study_id
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