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
Overview
- Phase
- Phase 2
- Intervention
- SP-103
- Conditions
- Moderate to Severe Acute Lower Back Pain
- Sponsor
- Scilex Pharmaceuticals, Inc.
- Enrollment
- 75
- Locations
- 9
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
SP-103
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
Intervention: SP-103
Placebo
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse Events
Time Frame: 28 days
Numeric Pain Rating Scale (0-10, 0 is no pain, 10 is worst pain imaginable)
Time Frame: 7 days
Secondary Outcomes
- Oswestry Disability Index (0-100, 0 is with no disability, 100 is the maximum disability)(Day 7 and 28)