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

This study has been completed.
Sponsor:
Collaborators:
Worldwide Clinical Trials Ltd.
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
  Purpose

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.


Condition Intervention Phase
Post-operative Pain
Drug: Ibuprofen/acetaminophen
Drug: Ibuprofen/acetaminophen (higher dose)
Drug: Nurofen Plus®
Drug: Panadeine® Extra
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • SPRID (the sum of the pain intensity difference (PID) and the pain relief (PR) score) [ Time Frame: 0-12h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 678
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen/acetaminophen (lower dose)
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet
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
Experimental: Ibuprofen/acetaminophen (higher dose)
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg
Drug: Ibuprofen/acetaminophen (higher dose)
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg
Other Name: Formulation reference number FR005/28
Active Comparator: Nurofen Plus®
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)
Drug: Nurofen Plus®
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)
Other Name: Reference number LOT 25W
Active Comparator: Panadeine® Extra
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)
Drug: Panadeine® Extra
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)
Other Name: Reference number 114555
Placebo Comparator: Placebo
Two placebo tablets
Drug: Placebo
Two placebo tablets
Other Name: Formulation reference number FR06/01

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229449

Locations
United States, Texas
Premier Research
Austin, Texas, United States, 78705
Sponsors and Collaborators
Reckitt Benckiser LLC
Worldwide Clinical Trials Ltd.
Premier Research Group plc
ACM Laboratories
Aptuit Inc.
Clearcut Clinical Consulting
Investigators
Principal Investigator: Stephen Daniels Premier Research Group Inc
  More Information

No publications provided

Responsible Party: Dr Phillip Berry, Reckitt Benckiser Inc
ClinicalTrials.gov Identifier: NCT01229449     History of Changes
Other Study ID Numbers: NL0811
Study First Received: October 26, 2010
Last Updated: October 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Reckitt Benckiser LLC:
Dental pain
Ibuprofen
Acetaminophen
Nurofen Plus®
Panadeine® Extra

Additional relevant MeSH terms:
Pain, Postoperative
Toothache
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Acetaminophen
Ibuprofen
Codeine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014