Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
- Conditions
- Lumbosacral Radicular Pain
- Interventions
- Drug: PlaceboDrug: SP-102
- Registration Number
- NCT03372161
- Lead Sponsor
- Scilex Pharmaceuticals, Inc.
- Brief Summary
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
- Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
- 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.
Main
- Has radiologic evidence of a condition that would compromise study outcomes.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo SP-102 SP-102 SP-102
- Primary Outcome Measures
Name Time Method Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg Baseline, 4 Weeks The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI) Baseline, 4 Weeks The ODI is the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI is a questionnaire completed by the subject that assesses10 topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question was scored on a scale of 0-5 with 0 indicating the least amount of disability and 5 indicating the most severe disability. The scores for all questions answered were summed, then multiplied by 2 to obtain the index (range 0 to 100). Zero was equated with no disability and 100 was the maximum disability possible.
Trial Locations
- Locations (37)
Semnur Research Site 49
🇺🇸Saint Petersburg, Florida, United States
Semnur Research Site 13
🇺🇸Tampa, Florida, United States
Semnur Research Site 48
🇺🇸Charleston, South Carolina, United States
Semnur Research Site 77
🇺🇸Greenville, South Carolina, United States
Semnur Research Site 51
🇺🇸Burlington, Massachusetts, United States
Semnur Research Site 63
🇺🇸Chicago, Illinois, United States
Semnur Research Site 12
🇺🇸Chicago, Illinois, United States
Semnur Research Site 60
🇺🇸Las Vegas, Nevada, United States
Semnur Research Site 58
🇺🇸Tempe, Arizona, United States
Semnur Research Site 47
🇺🇸Laguna Woods, California, United States
Semnur Research Site 75
🇺🇸Mobile, Alabama, United States
Semnur Research Site 52
🇺🇸Phoenix, Arizona, United States
Semnur Research Site 18
🇺🇸La Jolla, California, United States
Semnur Research Site 56
🇺🇸Fernandina Beach, Florida, United States
Semnur Research Site 81
🇺🇸Jacksonville, 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 38
🇺🇸Boise, Idaho, United States
Semnur Research Site 10
🇺🇸Newnan, Georgia, United States
Semnur Reseach Site 62
🇺🇸Overland Park, Kansas, United States
Semnur Research Site 65
🇺🇸Omaha, Nebraska, United States
Semnur Research Site 30
🇺🇸Shrewsbury, New Jersey, United States
Semnur Research Site 43
🇺🇸Cuyahoga Falls, Ohio, United States
Semnur Research Site 15
🇺🇸Houston, Texas, United States
Semnur Research Site 36
🇺🇸Oklahoma City, Oklahoma, United States
Semnur Research Site 35
🇺🇸Tyler, Texas, United States
Semnur Research Site 19
🇺🇸Chicago, Illinois, United States
Semnur Research Site 70
🇺🇸Los Gatos, California, United States
Semnur Research Site 40
🇺🇸Bloomington, Illinois, 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 59
🇺🇸Draper, Utah, United States
Semnur Research Site 42
🇺🇸Greenfield, Wisconsin, United States
Semnur Research Site 54
🇺🇸Plano, Texas, United States