Phase 3
N=106
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01266161 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12) — 18.2; 41.5 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibuprofen 600 mg ER (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12) |
18.2; 41.5 | <0.001 sig |
| PRIMARY Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose |
10.3; 18.4 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Intensity Difference (SPID) Scores |
4.1; 12.8; 2.5; 5.5; 12.5; 18.7 | <0.001 sig |
| SECONDARY Time to First Dose of Rescue Medication After First Dose of Study Drug |
1.6; NA | <0.001 sig |
| SECONDARY Percentage of Participants Taking Rescue Medication |
76.9; 29.6; 30.8; 5.6; 32.7; 9.3 | <0.001 sig |
| SECONDARY Pain Relief (PR) Scores |
0.4; 1.3; 0.7; 2.2; 0.6; 2.6 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) Scores |
0.1; 0.5; 0.1; 1.0; 0.0; 1.2 | <0.001 sig |
| SECONDARY Pain Relief Combined With Pain Intensity (PRID) Scores |
0.6; 1.8; 0.8; 3.2; 0.6; 3.8 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Relief Scores (TOTPAR) |
14.1; 28.7; 7.8; 12.9 | <0.001 sig |
| SECONDARY Number of Doses of Rescue Medication Used |
1.3; 0.4; 0.4; 0.1; 0.5; 0.1 | <0.001 sig |
| SECONDARY Time to Confirmed First Perceptible Relief |
NA; 25.0 | — |
| SECONDARY Time to Meaningful Relief |
NA; 54.2 | — |
| SECONDARY Participant Global Evaluation Score |
1.2; 3.5; 1.7; 3.7 | <0.001 sig |
Summary
The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
Eligibility Criteria
Inclusion Criteria
- Males and females 16 to 40 years of age
- Subjects who undergo surgical removal of at least two third molars
- One of which must be a partial or full bony mandibular impaction
- Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)
Exclusion Criteria
- Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
- Presence or history of any significant organ disease
- Use of prescription or OTC first generation antihistamines
- Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy
Data sourced from ClinicalTrials.gov (NCT01266161). 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.