Maxigesic USA Acute Dental Pain Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01420653
• Date of registration: 16/08/2011
• Primary sponsor: AFT Pharmaceuticals, Ltd.
• Public title: Maxigesic USA Acute Dental Pain Study
• Scientific title: Maxigesic USA Acute Dental Pail Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic USA Versus Acetaminophen, Ibuprofen and Placebo in Participants With Moderate to Severe Pain From Removal of at Least Two Third Molars
• Date of first enrolment: January 2012
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01420653
• Study type: Interventional
• Study design: N/A

Countries of recruitment

New Zealand

Contacts

• Name: John Currie

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Moderate to Severe Postoperative Pain

Intervention(s)

Drug: Acetaminophen

Drug: Ibuprofen

Drug: Maxigesic USA

Drug: Placebo

Secondary ID(s)

AFT-MX-6

Source(s) of Monetary Support

Please refer to primary and secondary sponsors