Trial Outcomes & Findings for Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain (NCT NCT05096494)
NCT ID: NCT05096494
Last Updated: 2026-07-06
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Day 1 to 7
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
Placebo
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Placebo: Placebo topical system is worn daily for 12 hours per day for 28 days
|
SP-103
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
SP-103: SP-103 topical system is worn daily for 12 hours per day for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Placebo: Placebo topical system is worn daily for 12 hours per day for 28 days
|
SP-103
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
SP-103: SP-103 topical system is worn daily for 12 hours per day for 28 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawn by sponsor
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
only female population included.
Baseline characteristics by cohort
| Measure |
SP-103
n=38 Participants
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
SP-103: SP-103 topical system is worn daily for 12 hours per day for 28 days
|
Placebo
n=37 Participants
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Placebo: Placebo topical system is worn daily for 12 hours per day, for 28 days
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=38 Participants
|
33 Participants
n=37 Participants
|
66 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=38 Participants
|
4 Participants
n=37 Participants
|
9 Participants
n=75 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=38 Participants
|
22 Participants
n=37 Participants
|
46 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=38 Participants
|
15 Participants
n=37 Participants
|
29 Participants
n=75 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=38 Participants
|
9 Participants
n=37 Participants
|
21 Participants
n=75 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=38 Participants
|
28 Participants
n=37 Participants
|
52 Participants
n=75 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=38 Participants
|
3 Participants
n=37 Participants
|
3 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=38 Participants
|
34 Participants
n=37 Participants
|
72 Participants
n=75 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=38 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=75 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
37 participants
n=37 Participants
|
75 participants
n=75 Participants
|
|
Fertility Status
Childbearing Potential
|
10 Participants
n=24 Participants • only female population included.
|
6 Participants
n=22 Participants • only female population included.
|
16 Participants
n=46 Participants • only female population included.
|
|
Fertility Status
Post-menopausal
|
6 Participants
n=24 Participants • only female population included.
|
7 Participants
n=22 Participants • only female population included.
|
13 Participants
n=46 Participants • only female population included.
|
|
Fertility Status
Surgically Sterile
|
8 Participants
n=24 Participants • only female population included.
|
9 Participants
n=22 Participants • only female population included.
|
17 Participants
n=46 Participants • only female population included.
|
|
Height
|
170.782 cm
n=38 Participants
|
171.162 cm
n=37 Participants
|
170.969 cm
n=75 Participants
|
|
Weight
|
87.314 kg
n=38 Participants
|
86.686 kg
n=37 Participants
|
87.005 kg
n=75 Participants
|
|
BMI
|
29.78 kg/m^2
n=38 Participants
|
29.54 kg/m^2
n=37 Participants
|
29.66 kg/m^2
n=75 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 7Population: mITT
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).
Outcome measures
| Measure |
SP-103
n=38 Participants
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
SP-103: SP-103 topical system is worn daily for 12 hours per day for 28 days
|
Placebo
n=37 Participants
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Placebo: Placebo topical system is worn daily for 12 hours per day, for 28 days
|
|---|---|---|
|
Numeric Pain Rating Scale Summed Pain Intensity Difference
|
5.44 units on a scale
Standard Error 1.916
|
8.97 units on a scale
Standard Error 1.867
|
SECONDARY outcome
Timeframe: Baseline, Day 7 and 28Population: mITT
Mean Oswestry Disability Index Total Score at Baseline, D7 and D28. The ODI assesses degree of disability where higher scores indicate greater disability.
Outcome measures
| Measure |
SP-103
n=38 Participants
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
SP-103: SP-103 topical system is worn daily for 12 hours per day for 28 days
|
Placebo
n=37 Participants
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Placebo: Placebo topical system is worn daily for 12 hours per day, for 28 days
|
|---|---|---|
|
Oswestry Disability Index (0-100, 0 is With no Disability, 100 is the Maximum Disability)
Baseline
|
32.8 score on a scale
Standard Deviation 13.29
|
30.2 score on a scale
Standard Deviation 12.87
|
|
Oswestry Disability Index (0-100, 0 is With no Disability, 100 is the Maximum Disability)
Day 7
|
25.4 score on a scale
Standard Deviation 11.43
|
22.8 score on a scale
Standard Deviation 13.11
|
|
Oswestry Disability Index (0-100, 0 is With no Disability, 100 is the Maximum Disability)
Day 28
|
21.7 score on a scale
Standard Deviation 13.08
|
21.2 score on a scale
Standard Deviation 12.81
|
SECONDARY outcome
Timeframe: D7 and D28Population: mITT
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.
Outcome measures
| Measure |
SP-103
n=38 Participants
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
SP-103: SP-103 topical system is worn daily for 12 hours per day for 28 days
|
Placebo
n=37 Participants
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Placebo: Placebo topical system is worn daily for 12 hours per day, for 28 days
|
|---|---|---|
|
Patient Global Impression of Change at D7 and D28
Day 7 · Much improved [2]
|
6 Participants
|
7 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · Not assessed [0]
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · Very much worse [7]
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 7 · Not assessed [0]
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 7 · Very much improved [1]
|
4 Participants
|
4 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 7 · Minimally improved [3]
|
11 Participants
|
11 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 7 · No change [4]
|
12 Participants
|
10 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 7 · Minimally worse [5]
|
1 Participants
|
2 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 7 · Much worse [6]
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 7 · Very much worse [7]
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · Very much improved [1]
|
8 Participants
|
8 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · Much improved [2]
|
7 Participants
|
8 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · Minimally improved [3]
|
11 Participants
|
8 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · No change [4]
|
9 Participants
|
9 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · Minimally worse [5]
|
0 Participants
|
4 Participants
|
|
Patient Global Impression of Change at D7 and D28
Day 28/EOT · Much worse [6]
|
0 Participants
|
0 Participants
|
Adverse Events
SP-103
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SP-103
n=38 participants at risk
One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back.
SP-103: SP-103 topical system is worn daily for 12 hours per day for 28 days
|
Placebo
n=37 participants at risk
One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back
Placebo: Placebo topical system is worn daily for 12 hours per day, for 28 days
|
|---|---|---|
|
Nervous system disorders
headache
|
0.00%
0/38 • 28 days
|
8.1%
3/37 • Number of events 4 • 28 days
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
2/38 • Number of events 2 • 28 days
|
0.00%
0/37 • 28 days
|
|
General disorders
Application site irritation
|
7.9%
3/38 • Number of events 3 • 28 days
|
0.00%
0/37 • 28 days
|
|
General disorders
Application site pruritus
|
2.6%
1/38 • Number of events 1 • 28 days
|
5.4%
2/37 • Number of events 2 • 28 days
|
Additional Information
Chris Ambrose, Director, Clinical Operations
Scilex Pharmaceuticals Inc. (Scilex Holding Company)
Phone: +1-650-386-6709
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place