Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05096494 | Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain | PHASE2 | COMPLETED | 75 | — | — | Apr 29, 2022 | May 30, 2023 | May 24, 2024 | 10 | United States |
| Arm | Type | Description |
|---|---|---|
| SP-103 | EXPERIMENTAL | One SP-103 transdermal system is worn 12 hours per day for 28 days on the lower back. |
| Placebo | PLACEBO_COMPARATOR | One placebo transdermal system is worn for 12 hours per day for 28 days on the lower back |
| Name | Type | Description |
|---|---|---|
| SP-103 | DRUG | SP-103 topical system is worn daily for 12 hours per day for 28 days |
| Placebo | DRUG | Placebo topical system is worn daily for 12 hours per day, for 28 days |
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 month...