Phase 2b Trial of a Na V 1.8 Inhibitor for Acute Pain
Authors' conclusion
LTG-001 led to significantly greater reductions in pain scores than placebo over the course of 48 hours after abdominoplasty.
Study context
- Population
- Patients with moderate-to-severe pain after abdominoplastyrandomised
- Participants
- 343 patients
- Comparison
- LTG-001 or hydrocodone bitartrate-acetaminophen vs placebo
- Primary endpoint
- Time-weighted sum of pain-intensity difference (SPID48; NRS 0–10; higher SPID48 = greater pain reduction)
- Follow-up
- 48-hour treatment period
Methodological detailsphase 2b, double-blind, placebo-controlled
- Phase 2b
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Least-squares mean difference
37.82
P = 0.003
Low dose
Least-squares mean difference
62.08
P < 0.001
High dose
Least-squares mean difference
40.86
Hydrocodone bitartrate-acetaminophen
Low dose
161.05
least-squares mean · 95% CI 142.93–179.16
High dose
185.30
least-squares mean · 95% CI 167.26–203.34
Hydrocodone bitartrate-acetaminophen
164.08
least-squares mean · 95% CI 146.02–182.14
Placebo
123.22
least-squares mean · 95% CI 105.23–141.21
Secondary outcomes
| Outcome | High dose | Placebo | P value |
|---|---|---|---|
| Opioid rescue medication consumedHigh dose vs Placebo | 11.00 MME | 18.35 MME | P = 0.01 |
| No receipt of opioid rescue medicationHigh dose vs Placebo | 52% | 22% | P < 0.001 |
Opioid rescue medication consumed
- Low dose not associated with significantly lower opioid use than placebo
No receipt of opioid rescue medication
- Low dose not associated with a significantly higher percentage than placebo
Safety
| Outcome | High dose | Placebo |
|---|---|---|
| Pyrexia | 7% | 2% |
| Presyncope | 6% | 1% |
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →