Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction

NCT ID: NCT00954356

Last Updated: 2012-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Dental Pain

Keywords

Pain following 3rd molar/wisdom tooth extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XPF-001

Group Type: EXPERIMENTAL

XPF-001

Intervention Type: DRUG

Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules)

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Single oral administration of 5 x 100 mg Placebo capsules.

Interventions

XPF-001

Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules)

Intervention Type: DRUG

placebo

Single oral administration of 5 x 100 mg Placebo capsules.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xenon Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Christensen, DDS

Role: PRINCIPAL_INVESTIGATOR

Jean Brown Research

Locations

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

XPF-001-201

Identifier Type: -

Identifier Source: org_study_id