Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT05485805
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2022-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
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
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-003274-22 | EUDRACT_NUMBER | None | View |