check_circleStudy Completed
Postoperative dental pain
Bayer Identifier:
22093
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
16 - N/ATrial summary
Enrollment Goal
541Trial Dates
September 2022 - January 2024Phase
Phase 3Could I Receive a placebo
YesProducts
Naproxen sodium and caffeine (BAY2880376)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | JBR Clinical Research | Salt Lake City, 84107, United States |
Primary Outcome
- Sum of pain intensity difference (SPID) over 8 hours post-dosedate_rangeTime Frame:Up to 8 hours post-dose
Secondary Outcome
- Sum of pain intensity differences from 0 to 2, 4, 6, 12 and 24 hours post-dosedate_rangeTime Frame:from 0 to 2, 4, 6, 12 and 24 hours post-dose
- Total pain relief (TOTPAR) from 0 to 2, 4, 6, 8, 12 and 24 hours post-dosedate_rangeTime Frame:up to 24 hours post-dose
- Time to first use of rescue medicationdate_rangeTime Frame:Up to 24 hours post-dose
- The cumulative proportion of participants taking rescue medication over the 24 hour perioddate_rangeTime Frame:Up to 24 hours post-dose
- Time to first perceptible relief measured by a stopwatchdate_rangeTime Frame:Up to 24 hours post-dose
- Time to meaningful relief measured by a stopwatchdate_rangeTime Frame:Up to 24 hours post-dose
- Time to first perceptible relief confirmed by meaningful relief defined as the time to perceptible pain reliefdate_rangeTime Frame:Up to 24 hours post-dose
- Pain intensity difference (PID)date_rangeTime Frame:up to 24 hours post-dose
- Pain relief scorePain Relief Score (PRS): 0 = No Relief; 1 = A Little Relief; 2 = Some Relief; 3 = A Lot of Relief; 4 = Complete Relief.date_rangeTime Frame:Up to 24 hours post-dose
- Peak pain intensity difference (PID)date_rangeTime Frame:Up to 24 hours post-dose
- Number of participants with certain peak pain relief scoreNumber of participants with pain relief score 4, 3, 2, 1date_rangeTime Frame:Up to 24 hours post-dose
- Cumulative percent of participants with ‘at least a 2-point PID’ over timedate_rangeTime Frame:Up to 24 hours post-dose
- Global assessment of pain relief of the investigational productNumber of participants with overall rating poor, fair, good, very good, excellent 24 hour post-dosedate_rangeTime Frame:24 hours post-dose
- Number of participants with adverse eventsdate_rangeTime Frame:Up to 5 days post-dose
- Number of participants with significant changes in vital signs since baselinedate_rangeTime Frame:Up to 5 days post-dose
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
5