# Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction

> **NCT03127592** · PHASE3 · TERMINATED · sponsor: **Apsen Farmaceutica S.A.** · enrollment: 140 (actual)

## Conditions studied

- Pain, Acute

## Interventions

- **DRUG:** Fixed Dose Combination
- **DRUG:** Etodolac
- **DRUG:** Cyclobenzaprine

## Key facts

- **NCT ID:** NCT03127592
- **Lead sponsor:** Apsen Farmaceutica S.A.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-10-05
- **Primary completion:** 2022-07-26
- **Final completion:** 2022-07-26
- **Target enrollment:** 140 (ACTUAL)
- **Why stopped:** recruitment difficulty
- **Last updated:** 2023-02-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03127592

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03127592, "Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction". Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/clinical/NCT03127592. Licensed CC0.

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