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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01420653
Registration number
NCT01420653
Ethics application status
Date submitted
16/08/2011
Date registered
22/08/2011
Date last updated
6/12/2018
Titles & IDs
Public title
Maxigesic 325 Acute Dental Pain Study
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Scientific title
Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain
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Secondary ID [1]
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AFT-MX-6
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dental Pain
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Maxigesic 325
Treatment: Drugs - Acetaminophen
Treatment: Drugs - Ibuprofen
Treatment: Drugs - Placebo
Experimental: Maxigesic 325 - Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Active Comparator: Acetaminophen - Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Active Comparator: Ibuprofen - Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Placebo Comparator: Placebo - Placebo tablets, every 6 hours, orally
Treatment: Drugs: Maxigesic 325
Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
Treatment: Drugs: Acetaminophen
Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
Treatment: Drugs: Ibuprofen
Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
Treatment: Drugs: Placebo
placebo, three tablets four times a day, with food for 48 hours
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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SPID (Summed Pain Intensity Differences)
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Assessment method [1]
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The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication.
This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference.
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Timepoint [1]
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48 hours afte the first dose
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Eligibility
Key inclusion criteria
- Provides written informed consent before initiation of any study-related procedures.
- Males and females aged at least 10 years and not more than 60 years old on the day of
consent.
- Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.
- A resting VAS pain intensity score at baseline (within 6 hours after the completion of
surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and
100 = worst pain imaginable.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery
other than asprin less than or equal to 150 mg/day
- Subjects who have received any anaesthetics within 24 hours prior to surgery
- Hypersensitivity to opioids
- Known to be pregnant or possibly pregnant
- Women of childbearing potential who are unwilling to take adequate contraceptive
precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier
method, or abstinence. A women of childbearing potential is defined as any female who
is less than 2 years post-menopausal or has not undergone a partial or total
hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral
oophorectomy.
- Women of childbearing potential who are unwilling to undergo an urine pregnancy test.
- Suffering from a neurological disorder relating to pain perception or any acute or
chronic condition that, in the opinion of the investigator, makes the subject
unsuitable from an efficacy or safety perspective.
- In the opinion of the investigator, unable to understand the visual analogue pain
score or comply with the protocol requirements.
- Currently, or in the last 30 days, has been in a clinical trial involving another
study drug.
- Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids
or topical steroids with the approval of the investigator) cyclosporin, tacrolimus or
methotrexate, or any other medication felt by the investigator to interfere with
safety or efficacy evaluations.
- Participant weight < 50 kg or > 120 kg.
- Has a history of drug or alcohol abuse.
- Suffering from any other disease or condition which, in the opinion of the
investigator, means that it would not be in the participants best interests to
participant in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2015
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Sample size
Target
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Accrual to date
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Final
408
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Texas
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Country [2]
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New Zealand
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State/province [2]
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Waikato
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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New Zealand
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State/province [4]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AFT Pharmaceuticals, Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are
greater than acetaminophen, ibuprofen or placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01420653
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John Currie, Doctor
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Address
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Clinical Trial New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01420653
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