# To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.

> **NCT02985671** · PHASE3 · UNKNOWN · sponsor: **Ache Laboratorios Farmaceuticos S.A.** · enrollment: 110 (estimated)

## Conditions studied

- Postural Low Back Pain
- Mechanical Low Back Pain

## Interventions

- **DRUG:** orphenadrine, acetaminophen, caffeine and diclofenac sodium
- **DRUG:** Diclofenac Sodium 50 MG
- **DRUG:** Placebo (for experimental drug)
- **DRUG:** Placebo (for Voltaren)

## Key facts

- **NCT ID:** NCT02985671
- **Lead sponsor:** Ache Laboratorios Farmaceuticos S.A.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** UNKNOWN
- **Start date:** 2021-01
- **Primary completion:** 2021-09
- **Final completion:** 2021-10
- **Target enrollment:** 110 (ESTIMATED)
- **Last updated:** 2020-09-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02985671

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02985671, "To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02985671. Licensed CC0.

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