Moderate to Severe Acute Lower Back PainPhase 2NCT05096494
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain
A Phase 2 study testing SP-103 in people with Moderate to Severe Acute Lower Back Pain, run by Scilex Pharmaceuticals, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Acute Lower Back Pain
- What is being tested?
- SP-103
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Apr 2022to 30 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Significant motor impairment, sensory deficits, pain in lower extremities, and/or new onset of bowel/bladder impairment based on history and neurological examination.
- History of fibromyalgia or diagnosis of fibromyalgia based on American College of Rheumatology 2016 criteria.
- History of malignancy or evidence of malignancy, lymphoproliferative, or neoplastic disease except for successfully treated basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia within 5 years.
- If female, is lactating/breastfeeding, plans to breastfeed, or plans to become pregnant while participating in the study.
- Known history of any clinically significant or unstable medical condition, any other disorder, condition or circumstance (including secondary gain) which in the opinion of the Investigator has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
- Has a serious illness that resulted in recent hospitalization.
- History of Myocardial Infarction within the last 6 months, New York Heart Association Class III or higher congestive heart failure, and any clinically significant ECG abnormality or arrhythmias.
- Has a hypersensitivity or allergy to the investigational compound/compound class being used in this study or any ingredients of this medication, including but not limited to lidocaine and amide compounds.
- Use of opioid and non-opioid analgesics for indications other than back pain.
- Use of any investigational drug and/or device within 28 days or is scheduled to receive an investigational drug other than blinded study drug while participating in the study.
- Involvement in an ongoing or planned worker's compensation claim, disability claim, or litigation related to any pain problem, receiving payments for a settled claim, awaiting pending payment for a settled claim, or any additional secondary gain in the opinion of the Investigator.
- Is an employee, family member, or student of the Investigator or clinical site.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Injury Care Research
Boise, Idaho, 83704
Scilex Research Site 08
Charleston, South Carolina, 29406
Chicago Anesthesia Research Specialists
Chicago, Illinois, 60657
Western Reserve Hospital
Cuyahoga Falls, Ohio, 44223
Costal Clinical Research Specialists
Fernandina Beach, Florida, 32034
Costal Clinical Research Specialists
Jacksonville, Florida, 32250
Horizon Clinical Research
Newnan, Georgia, 30265
Neuroscience Research Center
Overland Park, Kansas, 66210
Arizona Research Center
Phoenix, Arizona, 85053
Neuroscience Institute, Overlook Medical Center
Summit, New Jersey, 07901
About this study
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
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.
Read the 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, from days 1 through 28, and to record the time of investigational product applications and removals in an electronic diary.
Subjects will capture daily numeric pain rating scores and topical adhesions assessments in the electronic diary each evening prior to 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
- Being tested
- SP-103, Placebo
- Keywords
- lbp, lower back pain, lidocaine, topical system, patch
- Medical subject headings
- Hypotension, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-103Drug
SP-103 topical system is worn daily for 12 hours per day for 28 days
PlaceboDrug
Placebo topical system is worn daily for 12 hours per day, for 28 days
| Study group | Role | What they receive |
|---|---|---|
| SP-103 | Experimental | One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back. Receives: Drug: SP-103 |
| Placebo | Placebo comparator | One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale Summed Pain Intensity Difference
Average Lower Back Pain Numerical Pain Rating Scale Summed Pain Intensity Difference (SPID) D1 to D7 (0-10, 0 is no pain, 10 is worst pain imaginable). Daily average LBP NPRS scores, where subjects rated the intensity of their average LBP over the past 24 hours (higher scores are indicative of worse pain), were used to calculate time weighted SPID scores from D1 to D7. A higher SPID change score indicates less pain. The PID was calculated as the NPRS score at the Baseline minus the current day NPRS score. The SPID is the summed pain intensity difference for each Day (1-7).
Measured: Day 1 to 7
Secondary outcomes (2)
Oswestry Disability Index (0-100, 0 is With no Disability, 100 is the Maximum Disability)
Mean Oswestry Disability Index Total Score at Baseline, D7 and D28. The ODI assesses degree of disability where higher scores indicate greater disability.
Measured: Baseline, Day 7 and 28
Patient Global Impression of Change at D7 and D28
The PGIC assesses subject-rated improvement in condition compared to Baseline, with lower scores indicating greater improvement. The PGIC score was graded by the subject, scores range from 1 (very much improved) through 7 (very much worse) as assessed by the subject.
Measured: D7 and D28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start29 Apr 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Acute Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scilex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Dmitri Lissin, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096494
- Sponsor's protocol ID
- SP-103-02
- Status last verified
- Jun 2026
- First submitted
- 15 Oct 2021
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05096494
- Acronym / sponsor ID
- SP-103-02
- Conditions
- Moderate to Severe Acute Lower Back Pain
- Keywords
- lbp, lower back pain, lidocaine, topical system, patch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, from days 1 through 28, and to record the time of investigational product applications and removals in an electronic diary.
Subjects will capture daily numeric pain rating scores and topical adhesions assessments in the electronic diary each evening prior to the removal of investigational product.
On day 28, subjects will return to the study site to complete the End of Study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-103 | Experimental | Drug: SP-103One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back. |
| Placebo | Placebo comparator | Drug: PlaceboOne placebo transdermal system is worn for 12 hours per day for 28 days on the lower back |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-103SP-103 topical system is worn daily for 12 hours per day for 28 days | Drug | SP-103 |
| PlaceboPlacebo topical system is worn daily for 12 hours per day, for 28 days | Drug | Placebo |
Primary outcome
Numeric Pain Rating Scale Summed Pain Intensity Difference
Time frame: Day 1 to 7
Average Lower Back Pain Numerical Pain Rating Scale Summed Pain Intensity Difference (SPID) D1 to D7 (0-10, 0 is no pain, 10 is worst pain imaginable). Daily average LBP NPRS scores, where subjects rated the intensity of their average LBP over the past 24 hours (higher scores are indicative of worse pain), were used to calculate time weighted SPID scores from D1 to D7. A higher SPID change score indicates less pain. The PID was calculated as the NPRS score at the Baseline minus the current day NPRS score. The SPID is the summed pain intensity difference for each Day (1-7).
2 secondary outcomes
Oswestry Disability Index (0-100, 0 is With no Disability, 100 is the Maximum Disability)
Time frame: Baseline, Day 7 and 28
Patient Global Impression of Change at D7 and D28
Time frame: D7 and D28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Lissin study director
Chief Medical Officer
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SP-103 in people with Moderate to Severe Acute Lower Back Pain, run by Scilex Pharmaceuticals, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale Summed Pain Intensity Difference (time frame: Day 1 to 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.