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SP-103 for 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 day 7 and 28
Awards & highlights

Study Summary

This trial is testing a new drug, SP-103, to see if it is safe and effective for treating moderate to severe acute lower back pain.

Eligible Conditions
  • Lower Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7 and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Numeric Pain Rating Scale (0-10, 0 is no pain, 10 is worst pain imaginable)
Secondary outcome measures
Oswestry Disability Index (0-100, 0 is with no disability, 100 is the maximum disability)

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
61 Previous Clinical Trials
14,312 Total Patients Enrolled
Dmitri LissinStudy DirectorChief Medical Officer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Georgia
New Jersey
Kansas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Scilex Research Site 05
Scilex Research Site 07
Scilex Research Site 09
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have had lower back pain for years. Would love to help find better alternatives than physical therapy, surgery etc.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Scilex Research Site 07: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain
2022. "Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05096494.
~26 spots leftby Apr 2025
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