Phase 4 N=211 Randomized Double-blind Treatment

Study Comparing the Efficacy of Two Ibuprofen Formulations

Pain

Bottom Line

View on ClinicalTrials.gov: NCT00740857 ↗

Enrolled (actual)

211

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcome: Primary: Time to Meaningful Pain Relief — 45.4; 63.6 minutes — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: placebo (Drug); ibuprofen Formulation 1 (Drug); ibuprofen Formulation 2 (Drug)
Age: Pediatric, Adult · 16+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Meaningful Pain Relief	45.4; 63.6	<0.001 sig
SECONDARY Pain Intensity Difference (PID) Scores at Each Individual Time Points	0.1; 0.2; 0.1; 0.2; 0.8; 0.5	0.118
SECONDARY Pain Relief (PR) Scores at Individual Time Points	0.2; 0.5; 0.3; 0.6; 1.6; 1.0	0.041 sig
SECONDARY Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours	1.8; 7.8; 6.3; 6.5; 24.0; 23.0	<0.001 sig
SECONDARY Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points	0.3; 0.7; 0.4; 0.8; 2.4; 1.4	0.056
SECONDARY Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours	0.4; 2.8; 2.2; 1.4; 8.6; 8.1	<0.001 sig
SECONDARY Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours	1.4; 5.0; 4.1; 5.1; 15.4; 14.9	<0.001 sig
SECONDARY Time to First Perceptible Relief	23.7; 28.6	<0.001 sig

Summary

This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.

Eligibility Criteria

Inclusion criteria

Outpatients with post-operative pain following surgical extraction of third molars,
examined by the attending dentist or physician and medically cleared to participate in the study,
in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria

any serious medical condition,
acute localized dental infection at the time of surgery ,
females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00740857). 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.