Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 541 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05485805
The ClinicalTrials.gov registry entry for NCT05485805 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 541 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05485805 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.