Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
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ClinicalTrials.gov Identifier: NCT01229449 |
Recruitment Status
:
Completed
First Posted
: October 27, 2010
Last Update Posted
: October 27, 2010
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Sponsor:
Reckitt Benckiser LLC
Collaborators:
Worldwide Clinical Trials
Premier Research Group plc
ACM Laboratories
Aptuit Inc.
Clearcut Clinical Consulting
Information provided by:
Reckitt Benckiser LLC
Tracking Information | ||||
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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 |
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 |
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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 |
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Condition ICMJE | Post-operative Pain | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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 |
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Sex/Gender |
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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 |
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Investigators ICMJE |
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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 |