NCT01420653

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 Health

90
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2013

Geographic Reach
2 countries

4 active sites

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

First Submitted

Initial submission to the registry

August 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

December 6, 2018

Completed
Last Updated

December 6, 2018

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

August 16, 2011

Results QC Date

October 16, 2018

Last Update Submit

November 13, 2018

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (1)

  • SPID (Summed Pain Intensity Differences)

    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.

    48 hours afte the first dose

Study Arms (4)

Maxigesic 325

EXPERIMENTAL

Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally

Drug: Maxigesic 325

Acetaminophen

ACTIVE COMPARATOR

Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally

Drug: Acetaminophen

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Placebo tablets, every 6 hours, orally

Drug: Placebo

Interventions

Maxigesic 325DRUG

Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours

Also known as: Maxigesic
Maxigesic 325
AcetaminophenDRUG

Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours

Also known as: paracetamol
Acetaminophen
IbuprofenDRUG

Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.

Ibuprofen
PlaceboDRUG

placebo, three tablets four times a day, with food for 48 hours

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Premier Research

Austin, Texas, 78705, United States

Location

Clinical Trial New Zealand

Hamilton, Waikato Region, New Zealand

Location

Clinical Solutions Ltd.

Auckland, 0622, New Zealand

Location

Southern Clinical Trials

Christchurch, New Zealand

Location

Related Publications (1)

  • 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.

    PMID: 30245281DERIVED

MeSH Terms

Conditions

Toothache

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Results Point of Contact

Title
Jennifer Zhang
Organization
AFT Pharmaceuticals Ltd.
jenniferz@aftpharm.com
+ 64 9 488 0232

Study Officials

  • John Currie, Doctor

    Clinical Trial New Zealand

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 22, 2011

Study Start

April 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

December 6, 2018

Results First Posted

December 6, 2018

Record last verified: 2015-01

Locations

US(1)NZ(3)