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

NCT05096494 | Completed Phase 2 FDA Drug

• 1 other identifier: SP-103-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

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.

Conditions

Moderate to Severe Acute Lower Back Pain

Keywords

lbp; lower back pain; lidocaine; topical system; patch

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  28 days

• Numeric Pain Rating Scale (0-10, 0 is no pain, 10 is worst pain imaginable)

  7 days

Secondary Outcomes (1)

• Oswestry Disability Index (0-100, 0 is with no disability, 100 is the maximum disability)

  Day 7 and 28

Study Arms (2)

SP-103

EXPERIMENTAL

One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.

Drug: SP-103

Placebo

PLACEBO COMPARATOR

One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back

Drug: Placebo

Interventions

SP-103 DRUG

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

SP-103

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to read, write, and understand the informed consent prior to beginning any study procedures.
• Male or female, age 18 to 75 years (inclusive).
• Based on medical history, current episode of lower back pain (LBP) must have been present for not more than 3 months.
• Currently experiencing localized area of muscular tenderness in lower back area between the lowest rib and the gluteal fold in moderate-to-severe intensity as evaluated by the investigator.
• If deemed necessary by the Investigator, has a willing partner (facilitator) that can apply study drug to the designated anatomical area.
• Intact skin at the site of pain with no skin breakdown or inflammation.
• Negative urine drug screen.
• Average LBP numeric pain rating scale (NPRS) score of sufficient severity over the last 24 hours.
• Sufficiently compliant with electronic Diary entries.
• If a woman of childbearing potential (WOCBP) agrees to use an effective method of birth control during the study.
• If a WOCBP (i.e., not surgically sterile or at least 2 years postmenopausal), must have negative pregnancy tests.
• Have the means and willing to conduct a video-based televisits.
• Reviewed all study specific educational materials and has, in the opinion of the Investigator, the cognitive abilities to understand and appropriately complete all study mandated procedures.

You may not qualify if:

• A body mass index (BMI) ≥40 kg/m2
• Significant pain unrelated to LBP which, in the Investigator's and/or Sponsor's opinion, would significantly compromise assessment of LBP.
• Duration of current LBP episode greater than 3 months.
• Has LBP due to any of the following pathologies: infection, neoplasia, severe metabolic or structural disease of spine, lumbar radiculopathy, osteoporosis, hip dysplasia, inflammatory arthritis, ankylosing spondylitis, Paget's disease, cauda equina syndrome, gout, pseudogout, fibromyalgia, active post surgical pain, or pain over neurostimulator battery site.
• Has LBP caused by major trauma.
• Has had history of lower back surgery.
• Has excess hair that cannot be clipped (shaving/waxing is not permitted to the area), excess tattoo(s), or other dermatological conditions in the topical system application area that may interfere, in the opinion of the Investigator, with administration, efficacy, and safety evaluations.
• Use of Qutenza on the back within 3 months.
• Use of opioids for ≥4 days per week.
• Unwilling to discontinue all opioids, NSAIDs, other analgesics, or non-pharmacological therapy intended to treat LBP such as tapes (e.g., KT tape®), heated heat therapy (e.g., heat packs/pads, sauna, hot tub), or cold therapy (e.g., ice pack) for the duration of the trial.
• Unwilling to maintain the same regimen of physical activities throughout study participation.
• Anxiety or depression based on the Hospital Anxiety and Depression Scale scores, or has a major psychiatric disorder not controlled with medication that would interfere with clinical pain scores or participation in the trial.
• Alcohol dependence, illicit drug use based on urine screen (including recreational or medical use of tetrahydrocannabinol (THC) -containing substances, or non-prescribed use of controlled drug substances), or drug addiction.
• Current COVID-19 infection, if tested according to local requirements.
• Clinically significant abnormalities which, in the opinion of the Investigator, may compromise subject safety.

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead
• Worldwide Clinical Trials: collaborator

Study Sites (10)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Costal Clinical Research Specialists

Fernandina Beach, Florida, 32034, United States

Location

Costal Clinical Research Specialists

Jacksonville, Florida, 32250, United States

Location

Horizon Clinical Research

Newnan, Georgia, 30265, United States

Location

Injury Care Research

Boise, Idaho, 83704, United States

Location

Chicago Anaesthesia Research Specialists

Chicago, Illinois, 60657, United States

Location

Neuroscience Research Center

Overland Park, Kansas, 66210, United States

Location

Neuroscience Institute, Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

Western Reserve Hospital

Cuyahoga Falls, Ohio, 44223, United States

Location

Scilex Research Site 08

Charleston, South Carolina, 29406, United States

Location

MeSH Terms

Conditions

Hypotension; Low Back Pain

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitri Lissin

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: April 29, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)