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Nonsteroidal Anti-inflammatory Drug (NSAID)
Naproxen + Caffeine for Toothache
Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post-dose
Awards & highlights
Study Summary
This trial is testing whether a combination of naproxen sodium and caffeine is more effective than either alone in relieving pain after dental surgery.
Who is the study for?
This trial is for healthy individuals over 16 who've had dental surgery to remove molars and are experiencing moderate to severe pain. They shouldn't have taken any painkillers or certain supplements recently, must not consume a lot of caffeine, and should have a BMI between 18.5 and 35.Check my eligibility
What is being tested?
The study tests how well a combined tablet of naproxen sodium (an anti-inflammatory drug) and caffeine relieves post-dental surgery pain compared to each ingredient alone or placebo. Participants will be randomly assigned one of five treatments and their pain levels measured over eight hours.See study design
What are the potential side effects?
Possible side effects may include digestive issues like ulcers or bleeding, allergic reactions if sensitive to ingredients, increased heart rate due to caffeine, and potential interference with other medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sum of pain intensity difference (SPID) over 8 hours
Secondary outcome measures
Cumulative percent of participants with 'at least a 2-point PID' over time
Global assessment of the investigational product
Number of participants with adverse events
+12 moreSide effects data
From 2020 Phase 2 trial • 193 Patients • NCT041323366%
Vomiting
6%
Epistaxis
3%
Cellulitis
3%
Nausea
3%
Syncope
3%
Pyrexia
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Sodium/Caffeine-Dose 1
Naproxen Sodium/Caffeine-Dose 3
Naproxen Sodium
Caffeine
Naproxen Sodium/Caffeine-Dose 2
Placebo
Naproxen Sodium/Caffeine-Dose 4
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Naproxen sodium/caffeine - Dose 2Experimental Treatment1 Intervention
Participants will receive a single dose of two tablets of naproxen sodium/caffeine after extraction of third molars.
Group II: Naproxen sodium/caffeine - Dose 1Experimental Treatment1 Intervention
Participants will receive a single dose of one tablet of naproxen sodium/caffeine plus one tablet of placebo after extraction of third molars.
Group III: Naproxen sodiumExperimental Treatment1 Intervention
Participants will receive a single dose of one tablet of naproxen sodium plus one tablet of placebo after extraction of third molars.
Group IV: CaffeineExperimental Treatment1 Intervention
Participants will receive a single dose of two tablets of caffeine after extraction of third molars.
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of two tablets of matching placebo after extraction of third molars.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen sodium and caffeine (BAY2880376)
2022
Completed Phase 3
~550
Naproxen sodium (Aleve)
2019
Completed Phase 3
~740
Caffeine
2014
Completed Phase 3
~2980
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,437 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You regularly drink a lot of caffeine.The surgeon considers the surgery to have caused severe trauma.You are a healthy person who is able to walk around, and you are 16 years old or older.You have had important diseases or cancers in the past 5 years.Your body mass index (BMI) falls between 18.5 and 35.0, as measured by the National Institutes of Health (NIH) BMI Calculator.You have a lot of pain after surgery, scoring 5 or more on a scale of 0 to 10.You have taken medication for depression or any other mental health medication in the last 6 months.You have a related health condition like asthma.You have a current or past history of stomach or intestinal ulcers, bleeding, or other bleeding disorders.You are taking any medications that should not be used with the specific medications being tested.You have consumed caffeine within the last 2 days before the study.You have been taking pain medications, including opioids, for a long time.You need to have three or four specific teeth removed, and two of them must be lower molars. Upper molars can be removed no matter how they are positioned. The lower teeth must have mild or moderate damage and fit certain situations.You can only have short-acting local anesthesia before surgery, with or without certain additional medications as decided by the doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Naproxen sodium/caffeine - Dose 1
- Group 2: Placebo
- Group 3: Naproxen sodium/caffeine - Dose 2
- Group 4: Naproxen sodium
- Group 5: Caffeine
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being given this medication as part of the research?
"That is correct. The clinical trial listed on clinicaltrials.gov is actively recruiting patients as of today. This particular study was posted on September 21st, 2020 and last updated November 4th, 2020. They are looking for 528 individuals total from 1 location."
Answered by AI
Can anyone join this clinical trial at the moment?
"The listed information on clinicaltrials.gov indicates that this study is recruiting patients. This trial was originally posted on September 21st, 2020 and updated November 4th, 2020. The study requires 528 participants from 1 location."
Answered by AI
Has the Naproxen sodium (Aleve) undergone FDA approval?
"There is some clinical data supporting the efficacy of Naproxen sodium (Aleve), as well as multiple rounds of safety testing, so it received a score of 3."
Answered by AI
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