Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT05096494
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2021-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain
Sponsor:
Scilex Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: