Phase 3
N=374
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02863575 ↗Enrolled (actual)
374
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen — 55.5; 52.8 units on a scale — p=0.306
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibuprofen/Caffeine (Drug); Ibuprofen (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen |
55.5; 52.8 | 0.306 |
| SECONDARY Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8) |
13.3; 12.2; 2.2; 30.0; 28.5; 6.0 | 0.056 |
| SECONDARY Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8) |
8.7; 8.0; 1.2; 19.9; 18.8; 3.5 | 0.066 |
| SECONDARY Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8) |
4.6; 4.2; 1.0; 10.2; 9.7; 2.5 | 0.044 sig |
| SECONDARY Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose |
0.8; 0.8; 0.7; 3.3; 3.3; 1.0 | 0.975 |
| SECONDARY Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose |
0.4; 0.4; 0.3; 1.3; 1.2; 0.5 | 0.575 |
| SECONDARY Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose |
0.4; 0.5; 0.4; 2.0; 2.1; 0.6 | 0.808 |
| SECONDARY Time to Onset of Achieving Meaningful Relief |
46.60; 52.25; NA | 0.028 sig |
| SECONDARY Time to Onset of First Perceptible Relief |
25.80; 24.52; NA | 0.861 |
| SECONDARY Time to Treatment Failure |
NA; NA; 310.00 | 0.838 |
Summary
An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.
Eligibility Criteria
Inclusion Criteria
- Males and females 16 years to 40 years of age (inclusive).
- Subjects who have undergone outpatient surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction within 30 days of Screening and have met baseline pain criteria as described in this protocol
- Examined by the attending dentist or physician and medically cleared to participate in the study.
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator to place the subject at increased risk including the presence or history within 2 years of screening of the following medical conditions/disorders:
- Bleeding disorder;
- Gastrointestinal ulcer or gastrointestinal bleeding;
- Paralytic ileus or other gastrointestinal obstructive disorders.
- Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
- Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or other component of the product.
Data sourced from ClinicalTrials.gov (NCT02863575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.