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Skudexa for Acute Low Back Pain
NCT05170841Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2020
- Primary completion
- May 2022
- Countries
- 1
- Sponsor
- Menarini Group
- Modality
- Small Molecules
- Conditions
- acute low back pain
01
Overview
Phase 4, randomised, double-blind trial of dexketoprofen + tramadol in acute low back pain (4 arms), sponsored by Menarini Group. Primary endpoint: Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30% at 8 hours. Started Sep 2020; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Skudexa
Dexketoprofen/Tramadol combination throughout both phases.
Tramadol
Tramadol throughout both phases.
Placebo -> Skudexa
Placebo in single-dose phase, then Skudexa in multiple-dose phase.
Placebo -> Tramadol
Placebo in single-dose phase, then Tramadol in multiple-dose phase.
03
Who it enrols
Adult patients with moderate to severe acute low back pain (NRS >= 5) with onset within 48 hours. Excludes patients with neurological signs, recent analgesic use, history of substance abuse, or significant renal/hepatic/cardiac disease.
04
Endpoints
Primary
Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30%
Secondary
Total Pain Relief
Percentage of Maximum Total Pain Relief
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR
05
Results
Not all primary endpoints met
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