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

Reckitt Benckiser

Status and phase: Completed; Phase 3

Conditions: Post-operative Pain

Treatments: Drug: Nurofen Plus®; Drug: Ibuprofen/acetaminophen; Drug: Panadeine® Extra; Drug: Placebo; Drug: Ibuprofen/acetaminophen (higher dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229449

NL0811

Details and patient eligibility

About

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.

Full 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.

Enrollment: 678 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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678 participants in 5 patient groups, including a placebo group

Ibuprofen/acetaminophen (lower dose)

Experimental group

Description:

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

Treatment:

Drug: Ibuprofen/acetaminophen

Ibuprofen/acetaminophen (higher dose)

Experimental group

Description:

Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg

Treatment:

Drug: Ibuprofen/acetaminophen (higher dose)

Nurofen Plus®

Active Comparator group

Description:

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

Treatment:

Drug: Nurofen Plus®

Panadeine® Extra

Active Comparator group

Description:

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

Treatment:

Drug: Panadeine® Extra

Placebo

Placebo Comparator group

Description:

Two placebo tablets

Treatment:

Drug: Placebo