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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ibuprofen/acetaminophen (lower dose)

One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet

Group Type EXPERIMENTAL

Ibuprofen/acetaminophen

Intervention Type DRUG

One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water

Ibuprofen/acetaminophen (higher dose)

Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg

Group Type EXPERIMENTAL

Ibuprofen/acetaminophen (higher dose)

Intervention Type DRUG

Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water

Nurofen Plus®

Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)

Group Type ACTIVE_COMPARATOR

Nurofen Plus®

Intervention Type DRUG

Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water

Panadeine® Extra

Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)

Group Type ACTIVE_COMPARATOR

Panadeine® Extra

Intervention Type DRUG

Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water

Placebo

Two placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two placebo tablets, single dose taken orally with 300 ml water

Interventions

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Ibuprofen/acetaminophen

One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water

Intervention Type DRUG

Ibuprofen/acetaminophen (higher dose)

Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water

Intervention Type DRUG

Nurofen Plus®

Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water

Intervention Type DRUG

Panadeine® Extra

Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water

Intervention Type DRUG

Placebo

Two placebo tablets, single dose taken orally with 300 ml water

Intervention Type DRUG

Other Intervention Names

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Ibuprofen/paracetamol (lower dose) Ibuprofen/Paracetamol Ibuprofen/Codeine Acetaminophen/codeine Paracetamol/codeine

Eligibility Criteria

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Inclusion Criteria

Experiencing moderate to severe pain after extraction of impacted third molars

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No