Maxigesic 325 Acute Dental Pain Study

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AFT Pharmaceuticals, Ltd.
• Treatments: Acetaminophen; Ibuprofen

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.