NCT01229449

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

A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamol 500 mg; a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra) in Postoperative Adult Dental Pain Following Third Molar Extraction.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: Reckitt Benckiser LLC · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factorial with different mediators. The purpose of this study was to compare the efficacy and tolerability of ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics. The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Ibuprofen/acetaminophen	One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water
DRUG	Ibuprofen/acetaminophen (higher dose)	Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water
DRUG	Nurofen Plus®	Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water
DRUG	Panadeine® Extra	Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water
DRUG	Placebo	Two placebo tablets, single dose taken orally with 300 ml water

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2010-10-27
• Last updated: 2018-09-17
• Results posted: 2018-09-17

Locations

1 site across 1 country: United States