Maxigesic 325 Acute Dental Pain Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01420653
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : May 5, 2016
Information provided by (Responsible Party):
AFT Pharmaceuticals, Ltd.

Brief Summary:
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.

Condition or disease Intervention/treatment Phase
Dental Pain Drug: Maxigesic 325 Drug: Acetaminophen Drug: Ibuprofen Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Maxigesic 325
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Drug: Maxigesic 325
Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
Other Name: Maxigesic

Active Comparator: Acetaminophen
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Drug: Acetaminophen
Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
Other Name: paracetamol

Active Comparator: Ibuprofen
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Drug: Ibuprofen
Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.

Placebo Comparator: Placebo
Placebo tablets, every 6 hours, orally
Drug: Placebo
placebo, three tablets four times a day, with food for 48 hours

Primary Outcome Measures :
  1. SPID (Summed Pain Intensity Differences) [ Time Frame: 48 hours afte the first dose ]
    The time-adjusted SPIDs (Summed Pain Intensity Differences) of the VAS pain intensity scores up to 48 ours after the first dose of study medication.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01420653

United States, Texas
Premier Research
Austin, Texas, United States, 78705
New Zealand
Clinical Trial New Zealand
Hamilton, Waikato, New Zealand
Clinical Solutions Ltd.
Auckland, New Zealand, 0622
Southern Clinical Trials
Christchurch, New Zealand
Sponsors and Collaborators
AFT Pharmaceuticals, Ltd.
Principal Investigator: John Currie, Doctor Clinical Trial New Zealand

Responsible Party: AFT Pharmaceuticals, Ltd. Identifier: NCT01420653     History of Changes
Other Study ID Numbers: AFT-MX-6
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: January 2015

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action