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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
AFT-MX-6
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Pain 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SPID (Summed Pain Intensity Differences)
Timepoint [1] 0 0
48 hours afte the first dose

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
408
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
New Zealand
State/province [2] 0 0
Waikato
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AFT Pharmaceuticals, Ltd.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01420653
Trial related presentations / publications
Daniels SE, Atkinson HC, Stanescu I, Frampton C. Analgesic Efficacy of an Acetaminophen/Ibuprofen Fixed-dose Combination in Moderate to Severe Postoperative Dental Pain: A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial. Clin Ther. 2018 Oct;40(10):1765-1776.e5. doi: 10.1016/j.clinthera.2018.08.019. Epub 2018 Sep 21.
Public notes

Contacts
Principal investigator
Name 0 0
John Currie, Doctor
Address 0 0
Clinical Trial New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01420653