# A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo

> **NCT05485805** · PHASE3 · COMPLETED · sponsor: **Bayer** · enrollment: 541 (actual)

## Conditions studied

- Postoperative Dental Pain

## Interventions

- **DRUG:** Naproxen sodium and caffeine (BAY2880376)
- **DRUG:** Naproxen sodium (Aleve)
- **DRUG:** Caffeine
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05485805
- **Lead sponsor:** Bayer
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-09-21
- **Primary completion:** 2024-01-25
- **Final completion:** 2024-01-29
- **Target enrollment:** 541 (ACTUAL)
- **Last updated:** 2025-03-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05485805

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05485805, "A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT05485805. Licensed CC0.

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