Phase 3
N=218
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01216163 ↗Enrolled (actual)
218
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6) — 2.8; 20.0; 17.1 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Novel Ibuprofen (Drug); Acetaminophen (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6) |
2.8; 20.0; 17.1 | <0.001 sig |
| PRIMARY Time to Onset of Meaningful Relief |
NA; 58.0; 53.4 | <0.001 sig |
| SECONDARY Time to Confirmed First Perceptible Relief |
NA; 16.0; 23.7 | <0.001 sig |
| SECONDARY Pain Relief Rating (PRR) |
0.1; 0.7; 0.4; 0.3; 1.8; 1.5 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) |
-0.1; 0.3; 0.2; -0.1; 0.8; 0.5 | <0.001 sig |
| SECONDARY Sum of Pain Relief Rating and Pain Intensity Difference (PRID) |
0.1; 0.9; 0.6; 0.2; 2.5; 2.0 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Intensity Difference (SPID) |
-0.1; 2.2; 1.8; -0.1; 3.4; 2.8 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Relief Rating (TOTPAR) |
0.9; 4.7; 4.2; 1.4; 7.2; 6.4 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) |
0.9; 6.9; 6.0; 1.3; 10.6; 9.1 | <0.001 sig |
| SECONDARY Cumulative Percentage of Participants With Meaningful Relief |
0.0; 0.0; 0.0; 0.0; 21.6; 20.0 | <0.001 sig |
| SECONDARY Cumulative Percentage of Participants With Confirmed First Perceptible Relief |
2.2; 28.4; 24.7; 4.4; 64.8; 62.4 | <0.001 sig |
| SECONDARY Time to Treatment Failure |
1.6; NA; NA | <0.001 sig |
| SECONDARY Cumulative Percentage of Participants With Treatment Failure |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | <0.001 sig |
| SECONDARY Cumulative Percentage of Participants With Complete Relief |
0.0; 0.0; 1.2; 0.0; 6.8; 4.7 | 0.294 |
| SECONDARY Participant Global Evaluation of Study Medication |
0.9; 3.5; 3.0 | <0.001 sig |
Summary
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
Eligibility Criteria
Inclusion Criteria
- Normal, healthy males and females 16 to 40 years of age
- Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide
Exclusion Criteria
- Pregnancy or breast-feeding
- Alcohol or substance abuse
- Any serious medical or psychiatric disorder
- History of stomach ulcers, stomach bleed, or other bleeding disorders
- Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol])
Data sourced from ClinicalTrials.gov (NCT01216163). 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.