Phase 3
N=316
Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01098747 ↗Enrolled (actual)
316
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) — 5.4; 29.8 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Novel Ibuprofen (Drug); Standard Ibuprofen (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) |
5.4; 29.8 | <0.001 sig |
| PRIMARY Time to Onset of Meaningful Relief |
NA; 42.4; 55.3 | <0.001 sig |
| SECONDARY Time to Confirmed First Perceptible Relief |
NA; 16.4; 25.7 | <0.001 sig |
| SECONDARY Pain Relief Rating (PRR) |
0.4; 0.7; 0.5; 0.5; 2.0; 1.5 | 0.007 sig |
| SECONDARY Pain Intensity Difference (PID) |
0.0; 0.3; 0.1; 0.0; 1.0; 0.6 | <0.001 sig |
| SECONDARY Sum of Pain Relief Rating and Pain Intensity Difference (PRID) |
0.4; 1.1; 0.6; 0.6; 3.0; 2.1 | 0.001 sig |
| SECONDARY Time-weighted Sum of Pain Intensity Difference (SPID) |
0.1; 2.8; 2.4; 0.1; 4.4; 4.1 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Relief Rating (TOTPAR) |
1.3; 5.2; 4.6; 2.0; 8.1; 7.6 | < 0.001 sig |
| SECONDARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) |
1.3; 8.0; 7.0; 2.1; 12.6; 11.8 | <0.001 sig |
| SECONDARY Cumulative Percentage of Participants With Meaningful Relief |
0.0; 1.1; 0.6; 4.2; 28.4; 16.8 | 0.490 |
| SECONDARY Cumulative Percentage of Participants With Confirmed First Perceptible Relief |
6.3; 26.3; 12.1; 14.6; 84.2; 60.7 | 0.004 sig |
| SECONDARY Time to Treatment Failure |
1.7; 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; 0.0; 0.0; 6.3; 3.5 | 0.078 |
| SECONDARY Participant Global Evaluation of Study Medication |
1.1; 3.8; 3.7 | <0.001 sig |
Summary
This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen 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 drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants[including alcohol])
Data sourced from ClinicalTrials.gov (NCT01098747). 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.