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NCT05096494 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain
A Phase 2 study, sponsored by Scilex Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT05096494: Completed Phase 2 study, sponsored by Scilex Pharmaceuticals.
NCT05096494 is a Phase 2 study that has completed, run by Scilex Pharmaceuticals. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05096494, a Phase 2 study, has completed, sponsored by Scilex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study 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.
Primary Outcome
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 N
Interventions
- DRUG Placebo
- DRUG SP-103
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2022-04-29 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 2 |
What the finished NCT05096494 record still lists
NCT05096494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05096494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05096494 about?
NCT05096494 is a clinical study titled "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.
What is the current status of trial NCT05096494?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2022-04-29. Estimated completion is 2023-05-30.
What interventions are being tested in trial NCT05096494?
The interventions under investigation include: Placebo (DRUG), SP-103 (DRUG).
Who is sponsoring clinical trial NCT05096494?
This trial is sponsored by Scilex Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05096494's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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