Status:
COMPLETED
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Lead Sponsor:
Scilex Pharmaceuticals, Inc.
Collaborating Sponsors:
Worldwide Clinical Trials
Semnur Pharmaceuticals, Inc.
Conditions:
Lumbosacral Radicular Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Main
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2022
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT03372161
Start Date
December 8 2017
End Date
January 6 2022
Last Update
September 19 2022
Active Locations (37)
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1
Semnur Research Site 75
Mobile, Alabama, United States, 36605
2
Semnur Research Site 52
Phoenix, Arizona, United States, 85053
3
Semnur Research Site 58
Tempe, Arizona, United States, 85284
4
Semnur Research Site 18
La Jolla, California, United States, 92037