Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2
ConditionLumbosacral Radicular Pain
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSemnur Pharmaceuticals, Inc.
About this trial
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with moderate to severe sciatica (pain in the lower back, hips, buttocks and legs). SP-102, placebo (a medication that looks like SP-102 but does not contain any active ingredient), or an active comparator (dexamethasone sodium phosphate) is given once by the participant's healthcare professional. If a participant meets qualifications, each participant will have the option of receiving one supplemental open-label injection of SP-102, greater than four weeks and up to twenty weeks after their first injection.
The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain versus placebo. The study will also measure how well SP-102 relieves pain versus an active comparator medication (dexamethasone sodium phosphate). The study will also investigate the side effects of SP-102.
Eligibility criteria
Qualifiers
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 75 years (inclusive) at the Screening Visit.
A diagnosis of lumbosacral radicular pain (sciatica) present for at least 6 weeks and not more than 9 months prior to the Screening Visit.
Clinical symptoms consistent with the imaging (MRI)
Disqualifiers
Has a body mass index ≥40 kg/m2.
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.
Trial design
Treatments tested in this trial
- SP-102
- Placebo
- Dexamethasone Sodium Phosphate 10 MG/ML
Treatment groups
755 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov