deltatrials
Completed PHASE3 INTERVENTIONAL 5-arm 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

A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Pivotal Trial to Confirm the Efficacy of a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain

Sponsor: Bayer

Conditions Postoperative Dental Pain
Interventions Caffeine Naproxen sodium (Aleve) Naproxen sodium and caffeine (BAY2880376) Placebo
Updated 20 times since 2022 Last updated: Mar 7, 2025 Started: Sep 21, 2022 Primary completion: Jan 25, 2024 Completion: Jan 29, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05485805, this PHASE3 trial focuses on Postoperative Dental Pain and remains completed. Sponsored by Bayer, it has been updated 20 times since 2022, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – present · 15 months · monthly snapshot

Change History

20 versions recorded

  1. Apr 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Apr 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Mar 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  5. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

▶ Show 15 earlier versions

  1. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  2. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  3. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  4. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  5. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  6. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  7. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  8. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  9. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  10. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  11. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  12. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  13. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  14. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  15. Sep 2022 — Nov 2022 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bayer
Data source: Bayer

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations