Status:
COMPLETED
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Dental Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.
Eligibility Criteria
Inclusion
- Males (aged 18-60) and females of non-childbearing potential (aged 18-60;
- BMI between 19.5 to 32.0 kg/m2;
- Outpatient, scheduled to undergo surgical extraction of 2 or more impacted 3rd molars (with at least 1 partial bony mandibular extraction);
- use of only the following preoperative medications 2% lidocaine with epinephrine and nitrous oxide;
- Able to complete the requested information on analgesic questionnaires and able to comply with study procedures and restrictions;
- Able to read, comprehend and sign the consent form;
- Deemed medically healthy to participate in the study, with normal or clinically insignificant medical history, physical examination, lab tests and ECG results;
- No contraindications to the study drug, it excipients or any of the study medications including rescue medications.
Exclusion
- Presence of a clinically significant medical condition;
- Positive test for HIV, Hepatitis B or Hepatitis C;
- Use of any prescription or over the counter medication or supplement in the 48 hours before dose of study drug until discharge;
- Acute local infection at the time of dental surgery;
- Females who are pregnant, lactating or of child-bearing potential, or who provide a positive pregnancy test result at screening or check-in;
- Males not undertaking adequate measures to prevent their partner becoming pregnant throughout the study;
- Clinically significant laboratory values;
- Clinically significant abnormal ECG;
- History or presence of alcoholism, or alcohol or substance abuse (within previous 2 years), or routine consumption of 3 or more alcoholic drinks per day;
- A positive urine drug test;
- Routine use of analgesics 5 or more times per week;
- Presence or history (within 2 years of enrolment) of bleeding disorder(s) or peptic ulcer disease;
- History of allergic reaction to any drug, including penicillin;
- Ingestion of caffeine containing foods or drinks in the 24 hours before dose of study drug;
- Consumption of alcohol in the 48 hours before dose of study drug, or a positive alcohol breath test at check-in;
- Consumption of grapefruit or grapefruit containing products in the 7 days before dose of study drug;
- Use of tobacco or nicotine substitutes within 1 month of dose of study drug, or inability to refrain from use of nicotine between check-in and follow up;
- Treatment for depression in the 6 months prior to enrolment;
- Use of another investigational drug in the 60 days before enrolment;
- Donation or loss of 50-500 mL of blood in the 30 days prior to enrolment, or more than 500 mL of blood in the 56 days before enrolment;
- Previously entered into this study;
- Study site or Sponsor employees or relatives of employees directly involved in the study;
- Any other condition that (in the opinion of the Investigator or sponsor) makes the subject unsuitable for the study.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00954356
Start Date
September 1 2009
End Date
December 1 2009
Last Update
July 16 2012
Active Locations (1)
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1
Jean Brown Research
Salt Lake City, Utah, United States, 84124