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

Last updated: August 14, 2018
Sponsor: Reckitt Benckiser LLC
Overall Status: Completed

Phase

3

Condition

Oral Facial Pain

Acute And Chronic Dental Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT01229449
NL0811
  • Ages > 16
  • All Genders

Study 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

Inclusion

Main Inclusion Criteria: Experiencing moderate to severe pain after extraction of impacted third molars

Exclusion

Main Exclusion Criteria: Any ongoing painful condition other than that associated with the current third molarsurgery that could significantly interfere with the subject's suitability Any conditionthat would render the subject unsuitable to receive an NSAID, acetaminophen or codeine

Study Design

Total Participants: 678
Study Start date:
January 01, 2009
Estimated Completion Date:
September 30, 2009

Study 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.

Connect with a study center

  • Premier Research

    Austin, Texas 78705
    United States

    Site Not Available

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