NCT05096494

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Scilex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Three to 7 days after the Screening Visit, subjects will return for a Baseline visit to verify electronic Diary compliance, collect urine samples for a drug screen and pregnancy test (for women of child-bearing potential), and complete baseline clinical rating scales. If subjects meet all the study inclusion criteria and none of the exclusion criteria, subjects will be randomized into the study. Subjects are expected to apply investigational product for 12 hours per study day) study days 1 through 28 and to record the time of investigational product applications and removals an electronic diary. Subjects will capture daily numeric pain rating scores and topical adhesions assessments in the electronic diary each evening prior the removal of investigational product. On day 28, subjects will return to the study site to complete the End of Study visit.

Conditions

• Moderate to Severe Acute Lower Back Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-29
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2021-10-27
• Last updated: 2024-05-24

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study