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Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain

Phase 2
Waitlist Available
Research Sponsored by Scilex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing SP-103, a skin-applied treatment, to see if it can help people with severe lower back pain. Participants will use the treatment regularly and note their pain levels. The goal is to find out if SP-103 can effectively reduce their pain.

Eligible Conditions
  • Acute Lumbar Strain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SP-103Experimental Treatment1 Intervention
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
Group II: PlaceboPlacebo Group1 Intervention
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SP-103
2022
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

Scilex Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
878 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
65 Previous Clinical Trials
14,785 Total Patients Enrolled
Dmitri LissinStudy DirectorChief Medical Officer
~21 spots leftby Dec 2025
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