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Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2

NCT07579351 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 755

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Lumbosacral Radicular Pain

Interventions

DRUG

SP-102

One Injection

DRUG

Placebo

One injection

DRUG

Dexamethasone Sodium Phosphate 10 MG/ML

One injection

Sponsors & Collaborators

  • Syngene

    collaborator INDUSTRY

  • Cromos Pharma LLC

    collaborator INDUSTRY

  • Semnur Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-07-31
Completion
2029-01-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579351 on ClinicalTrials.gov