Phase 3 N=678 Randomized Quadruple-blind Treatment

Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study

Post-operative Pain

Bottom Line

View on ClinicalTrials.gov: NCT01229449 ↗

Enrolled (actual)

678

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) — 2.68; 3.30; 2.62; 1.93 units on a scale*hour — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ibuprofen/acetaminophen (Drug); Ibuprofen/acetaminophen (higher dose) (Drug); Nurofen Plus® (Drug); Panadeine® Extra (Drug); Placebo (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Reckitt Benckiser LLC
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)	2.68; 3.30; 2.62; 1.93; 0.54	<0.0001 sig
SECONDARY Change From Baseline in AUC (0-8h) of SPRID	3.65; 3.95; 3.44; 3.19; 0.61; 3.66	—
SECONDARY Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)	1.32; 1.46; 1.23; 1.13; 0.18; 1.32	—
SECONDARY Change From Baseline in AUC of Pain Relief Scores (TOTPAR)	2.33; 2.48; 2.20; 2.05; 0.42; 2.34	—
SECONDARY Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)	1.12; 1.29; 0.78; 1.01; 0.29; 2.49	—
SECONDARY Individual Pain Intensity Differences (Ordinal)	0.40; 0.46; 0.23; 0.31; 0.09; 0.94	—
SECONDARY Individual Pain Intensity Differences Visual Analogue Scale (VAS)	9.0; 10.5; 4.5; 8.7; 0.4; 22.8	—
SECONDARY Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)	1.78; 1.93; 1.74; 1.63; 0.60	—
SECONDARY Change From Baseline in Peak Pain Relief (PR)	3.06; 3.25; 2.98; 2.88; 0.96	—
SECONDARY Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication	15; 9; 15; 12; 43; 16	—

Summary

The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.

Eligibility Criteria

Main Inclusion Criteria: Experiencing moderate to severe pain after extraction of impacted third molars Main Exclusion Criteria: Any ongoing painful condition other than that associated with the current third molar surgery that could significantly interfere with the subject's suitability Any condition that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine

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Data sourced from ClinicalTrials.gov (NCT01229449). 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.