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NCT05485805 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 541
- Enrollment target
NCT05485805: Completed Phase 3 study, sponsored by Bayer.
NCT05485805 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 541 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05485805, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 541 participants
- Enrollment target
Study Summary
Researchers are looking for a better way to relieve pain in people, such as after dental surgery. Participants in this study, have had 3 or 4 third molars (cheek teeth) removed and subsequently have moderate to severe tooth pain. The study treatment naproxen sodium suppresses inflammatory pain by reducing inflammation. In the US, naproxen has been marketed since 1976, and naproxen sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea, or cocoa, has been shown to enhance the effect of various painkillers, and therefore is accepted as an additive. The main purpose of this study is to learn how well a fixed-dose combination of naproxen sodium and caffeine relieves pain compared to each single ingredient as well as to placebo in participants after molar removal. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the researchers will compare the amount of pain decrease over 8 hours in participants who received a single dose of either: * 1 fixed-dose tablet of naproxen sodium/caffeine * 2 fixed-dose tablets of naproxen sodium/caffeine * naproxen sodium only * caffeine only * or placebo The study participants will be randomly (by chance) assigned to one of the five treatment groups. They will take a single dose of two tablets by mouth within 4.5 hours after the surgery. If there is no pain relief within 2 hours after intake, other painkillers may be given.
Primary Outcome
Pain intensity scale is the Numerical Rating Scale measured from 0 to 10, where 0 indicates no pain and 10 means the wors pain imaginable. Pain intensity Difference (PID) is calculated by subtracting the pain intensity at different time points in the post-dose time point from the pain intensity at baseline. The summed pain intensity difference (SPID) is to be calculated by multiplying the PID score at each post dose time point by the duration (in hours) since the preceding time point and then
Interventions
- DRUG Placebo
- DRUG Caffeine
- DRUG Naproxen sodium (Aleve)
- DRUG Naproxen sodium and caffeine (BAY2880376)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 541 participants |
| Start Date | 2022-09-21 |
| Est. Completion | 2024-01-29 |
| Phase | Phase 3 |
What the finished NCT05485805 record still lists
NCT05485805 is an interventional study that assigns participants to a tested intervention. The registered 541 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05485805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05485805 about?
NCT05485805 is a clinical study titled "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". Researchers are looking for a better way to relieve pain in people, such as after dental surgery. Participants in this study, have had 3 or 4 third molars (cheek teeth) removed and subsequently have moderate to severe tooth pain. The study treatment naproxen sodium suppresses inflammatory pain by ...
What is the current status of trial NCT05485805?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 541 participants. The study started on 2022-09-21. Estimated completion is 2024-01-29.
What interventions are being tested in trial NCT05485805?
The interventions under investigation include: Placebo (DRUG), Caffeine (DRUG), Naproxen sodium (Aleve) (DRUG), Naproxen sodium and caffeine (BAY2880376) (DRUG).
Who is sponsoring clinical trial NCT05485805?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05485805's enrollment target sits among peer trials
541 694th of 2000 higher than 1,307 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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