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

Tracking Information
First Submitted Date ICMJE	October 26, 2010
First Posted Date ICMJE	October 27, 2010
Last Update Posted Date	October 27, 2010
Study Start Date ICMJE	January 2009
Actual Primary Completion Date	September 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 26, 2010)	SPRID (the sum of the pain intensity difference (PID) and the pain relief (PR) score) [ Time Frame: 0-12h ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: October 26, 2010)	SPID (Sum of Pain Intensity Difference) [ Time Frame: 0-4h, 0-6h, 0-8h, 0-12h ]; SPRID [ Time Frame: 0-4h, 0-6h and 0-8h ]; TOTPAR (Total Pain Relief) [ Time Frame: 0-4h, 0-6h, 0-8h and 0-12h ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Official Title ICMJE	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.
Brief 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 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Post-operative Pain
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 26, 2010)	678
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2009
Actual Primary Completion Date	September 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	16 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01229449
Other Study ID Numbers ICMJE	NL0811
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr Phillip Berry, Reckitt Benckiser Inc
Study Sponsor ICMJE	Reckitt Benckiser LLC
Collaborators ICMJE	Worldwide Clinical Trials; Premier Research Group plc; ACM Laboratories; Aptuit Inc.; Clearcut Clinical Consulting
Investigators ICMJE	Principal Investigator: Stephen Daniels Premier Research Group Inc
PRS Account	Reckitt Benckiser LLC
Verification Date	October 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP