Clinical trial NCT01229449: Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Official title: A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamol 500 mg; a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra) in Postoperative Adult Dental Pain Following Third Molar Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-operative Pain
Keywords: Dental pain
Ibuprofen
Acetaminophen
Nurofen Plus®
Panadeine® Extra
Paracetamol
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
name: Aptuit
First posted: 2010-10-27
Enrollment: 678
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Nurofen Plus® and Panadeine® Extra.

Detailed description: RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factorial with different mediators.

The purpose of this study was to compare the efficacy and tolerability of ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics.

The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
timeFrame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Secondary outcomes:
measure: Change From Baseline in AUC (0-8h) of SPRID
timeFrame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose
measure: Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
timeFrame: 0-4, 0-6, 0-8 and 0-12 hours
measure: Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
timeFrame: 0-4, 0-6, 0-8 and 0-12 hours
measure: Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
timeFrame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
measure: Individual Pain Intensity Differences (Ordinal)
timeFrame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
measure: Individual Pain Intensity Differences Visual Analogue Scale (VAS)
timeFrame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
measure: Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)
timeFrame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
measure: Change From Baseline in Peak Pain Relief (PR)
timeFrame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
measure: Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
timeFrame: At 12 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: Premier Research
state: Texas
Study officials:
affiliation: Premier Research Group Inc
name: Stephen Daniels
role: PRINCIPAL_INVESTIGATOR
References: