Clinical trial NCT00954356: Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
Official title: Single-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Safety, PK, & Efficacy of a Single Oral Dose of XPF-001 in the Treatment of Pain Related to Third Molar/Wisdom Tooth Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Keywords: Pain following 3rd molar/wisdom tooth extraction
Lead sponsor: Xenon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)
timeFrame: 6 hours post dose
Secondary outcomes:
measure: Total Pain Relief (TOTPAR) at 4 Hours Post Dose
timeFrame: 4 hours
measure: Total Pain Relief (TOTPAR) at 8 Hours Post Dose
timeFrame: 8 hours
measure: Total Pain Relief (TOTPAR) at 12 Hours Post Dose
timeFrame: 12 hours
measure: Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose
timeFrame: Baseline to 4 hours post dose
measure: Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose
timeFrame: Baseline to 6 hours post dose
measure: Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose
timeFrame: Baseline to 8 hours post dose
measure: Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose
timeFrame: Baseline to 12 hours post dose
measure: Time to First Perceptible Relief
timeFrame: 24 hours
measure: Time to Meaningful Relief
timeFrame: 24 hours
measure: Time to Rescue Medication
timeFrame: 24 hours
measure: Treatment Emergent Adverse Events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research
name: Steven Christensen, DDS
role: PRINCIPAL_INVESTIGATOR
References: