# Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain

> **NCT04968158** · PHASE3 · COMPLETED · sponsor: **Laboratorios Silanes S.A. de C.V.** · enrollment: 124 (actual)

## Conditions studied

- Acute Low Back Pain

## Interventions

- **DRUG:** Etoricoxib 90 mg / Tramadol 50 mg
- **DRUG:** Acetaminophen 325 mg / Tramadol 37.5 mg

## Key facts

- **NCT ID:** NCT04968158
- **Lead sponsor:** Laboratorios Silanes S.A. de C.V.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-11-29
- **Primary completion:** 2022-03-15
- **Final completion:** 2022-04-10
- **Target enrollment:** 124 (ACTUAL)
- **Last updated:** 2022-04-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04968158

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04968158, "Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT04968158. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
