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



Status:Completed
Conditions:Post-Surgical Pain, Hospital, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Musculoskeletal, Other
Healthy:No
Age Range:16 - Any
Updated:9/19/2018
Start Date:January 2009
End Date:September 2009

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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.

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.

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.

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
We found this trial at
1
site
Austin, Texas 78705
?
mi
from
Austin, TX
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