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

NCT05096494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-05-24

No results posted yet for this study

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 in subjects with moderate to severe acute lower back pain.

Conditions

  • Moderate to Severe Acute Lower Back Pain

Interventions

DRUG

SP-103

SP-103 topical system is worn daily for 12 hours per day for 28 days

DRUG

Placebo

Placebo topical system is worn daily for 12 hours per day, for 28 days

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Scilex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dmitri Lissin · Chief Medical Officer

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
2022-04-29
Primary Completion
2023-05-30
Completion
2023-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05096494 on ClinicalTrials.gov