Phase 3
Completed N=401
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Lumbosacral Radicular Pain
Source: ClinicalTrials.gov NCT03372161 ↗
Enrolled (actual)
401
Serious AEs
0.5%
Results posted
Sep 2022
Primary outcomePrimary: Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg — -2.34; -1.16 Change in score on a scale from baseline
◆ Published Evidence
Emerging
7citations · ~4 / year
A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain.
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.
Linked Publications
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A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg |
-2.34; -1.16 | — |
| SECONDARY Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI) |
-10.89; -4.76 | — |
Eligibility Criteria
Main Inclusion Criteria:
- 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 Criteria:
- 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.
Data sourced from ClinicalTrials.gov (NCT03372161) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.