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Tachifene vs Brufen in Acute Low Back Pain
NCT05222724Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2021
- Primary completion
- Oct 2022
- Countries
- 2
- Sponsor
- Angelini Pharma
- Modality
- Small Molecules
- Conditions
- low back pain (LBP)
01
Overview
Phase 4, randomised, open-label trial of acetaminophen and ibuprofen in low back pain (LBP) (2 arms), sponsored by Angelini Pharma. Primary endpoint: Sum of Pain Intensity Differences at 3 days. Started Dec 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Tachifene
Paracetamol 500 mg/Ibuprofen 150 mg FDC (2 tablets TID)
Brufen
Ibuprofen 600 mg (1 tablet TID)
03
Who it enrols
Adults 18-64 with uncomplicated acute low back pain (VAS >= 40mm). Excludes pregnant/lactating women, those with recent opioid use, spinal surgery history, severe organ insufficiency, or anticoagulant therapy.
04
Endpoints
Primary
Sum of Pain Intensity Differences
Secondary
Change in Visual Analogue Scale
Change in hand-to-floor distance
Degree of improvement in functional disability
Patient's Global Impression
Clinical Global Impression
Frequency of Adverse Events
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