NCT01229449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
678

participants targeted

Target at P75+ for phase_3 postoperative-pain

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
7.9 years until next milestone

Results Posted

Study results publicly available

September 17, 2018

Completed
Last Updated

September 17, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

October 26, 2010

Results QC Date

July 11, 2011

Last Update Submit

August 14, 2018

Conditions

Post-operative Pain

Keywords

Dental painIbuprofenAcetaminophenNurofen Plus®Panadeine® ExtraParacetamol

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)

    SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'

    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 (9)

  • Change From Baseline in AUC (0-8h) of SPRID

    0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose

  • Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)

    0-4, 0-6, 0-8 and 0-12 hours

  • Change From Baseline in AUC of Pain Relief Scores (TOTPAR)

    0-4, 0-6, 0-8 and 0-12 hours

  • Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)

    15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours

  • Individual Pain Intensity Differences (Ordinal)

    15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours

  • +4 more secondary outcomes

Study Arms (5)

Ibuprofen/acetaminophen (lower dose)

EXPERIMENTAL

One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet

Drug: Ibuprofen/acetaminophen

Ibuprofen/acetaminophen (higher dose)

EXPERIMENTAL

Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg

Drug: Ibuprofen/acetaminophen (higher dose)

Nurofen Plus®

ACTIVE COMPARATOR

Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)

Drug: Nurofen Plus®

Panadeine® Extra

ACTIVE COMPARATOR

Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)

Drug: Panadeine® Extra

Placebo

PLACEBO COMPARATOR

Two placebo tablets

Drug: Placebo

Interventions

Ibuprofen/acetaminophenDRUG

One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water

Also known as: Ibuprofen/paracetamol (lower dose)
Ibuprofen/acetaminophen (lower dose)
Ibuprofen/acetaminophen (higher dose)DRUG

Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water

Also known as: Ibuprofen/Paracetamol
Ibuprofen/acetaminophen (higher dose)
Nurofen Plus®DRUG

Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water

Also known as: Ibuprofen/Codeine
Nurofen Plus®
Panadeine® ExtraDRUG

Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water

Also known as: Acetaminophen/codeine, Paracetamol/codeine
Panadeine® Extra
PlaceboDRUG

Two placebo tablets, single dose taken orally with 300 ml water

Placebo

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing moderate to severe pain after extraction of impacted third molars

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Premier Research

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Pain, PostoperativeToothache

Interventions

IbuprofenAcetaminophenCodeineacetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsTooth DiseasesStomatognathic DiseasesFacial Pain

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Clinical Research Director, Clinical Research
Organization
Reckitt Benckiser Healthcare International
clinicalrequests@rb.com

Study Officials

  • Stephen Daniels

    Premier Research Group Inc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2010

First Posted

October 27, 2010

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 17, 2018

Results First Posted

September 17, 2018

Record last verified: 2018-08

Locations

US(1)