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

Tracking Information

First Received Date ^ICMJE

October 26, 2010

Last Updated Date

October 26, 2010

Start Date ^ICMJE

January 2009

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

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: Double Blind (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

Enrollment ^ICMJE

678

Completion Date

September 2009

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

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

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

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