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

This study has been completed.
Sponsor:
Collaborators:
Worldwide Clinical Trials
Premier Research Group plc
ACM Laboratories
Aptuit Inc.
Clearcut Clinical Consulting
Information provided by:
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01229449
First received: October 26, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 26, 2010
October 26, 2010
January 2009
September 2009   (final data collection date for primary outcome measure)
SPRID (the sum of the pain intensity difference (PID) and the pain relief (PR) score) [ Time Frame: 0-12h ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • SPID (Sum of Pain Intensity Difference) [ Time Frame: 0-4h, 0-6h, 0-8h, 0-12h ] [ Designated as safety issue: No ]
  • SPRID [ Time Frame: 0-4h, 0-6h and 0-8h ] [ Designated as safety issue: No ]
  • TOTPAR (Total Pain Relief) [ Time Frame: 0-4h, 0-6h, 0-8h and 0-12h ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
A Double-blind, Parallel-group, Placebo-controlled, Randomised, Single Dose Study to Compare Ibuprofen + Acetaminophen; Ibuprofen + Codeine (Nurofen Plus®) and Acetaminophen + Codeine (Panadeine® Extra) in Postoperative Dental Pain.
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 a combination of 400 mg ibuprofen plus 25.6 mg codeine (Nurofen Plus®) and a combination of 1000 mg acetaminophen plus 30 mg codeine (Panadeine® Extra) in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-operative Pain
  • Drug: Ibuprofen/acetaminophen
    One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet
    Other Names:
    • Formulation reference number FR005/28 for combination tablet
    • Formulation reference number FR06/01 for placebo
  • Drug: Ibuprofen/acetaminophen (higher dose)
    Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg
    Other Name: Formulation reference number FR005/28
  • Drug: Nurofen Plus®
    Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)
    Other Name: Reference number LOT 25W
  • Drug: Panadeine® Extra
    Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)
    Other Name: Reference number 114555
  • Drug: Placebo
    Two placebo tablets
    Other Name: Formulation reference number FR06/01
  • Experimental: Ibuprofen/acetaminophen (lower dose)
    One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet
    Intervention: Drug: Ibuprofen/acetaminophen
  • Experimental: Ibuprofen/acetaminophen (higher dose)
    Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg
    Intervention: Drug: Ibuprofen/acetaminophen (higher dose)
  • Active Comparator: Nurofen Plus®
    Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)
    Intervention: Drug: Nurofen Plus®
  • Active Comparator: Panadeine® Extra
    Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)
    Intervention: Drug: Panadeine® Extra
  • Placebo Comparator: Placebo
    Two placebo tablets
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
678
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01229449
NL0811
No
Not Provided
Not Provided
Dr Phillip Berry, Reckitt Benckiser Inc
Reckitt Benckiser LLC
  • Worldwide Clinical Trials
  • Premier Research Group plc
  • ACM Laboratories
  • Aptuit Inc.
  • Clearcut Clinical Consulting
Principal Investigator: Stephen Daniels Premier Research Group Inc
Reckitt Benckiser LLC
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP