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

NCT00954356 | Completed Phase 2 Results

• 1 other identifier: XPF-001-201
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)

  The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule. The higher the LS Means scores, the more pain relief was obtained. Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 6 score = 0, maximum possible score = 24

  6 hours post dose

Secondary Outcomes (11)

• Total Pain Relief (TOTPAR) at 4 Hours Post Dose

  4 hours

• Total Pain Relief (TOTPAR) at 8 Hours Post Dose

  8 hours

• Total Pain Relief (TOTPAR) at 12 Hours Post Dose

  12 hours

• Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose

  Baseline to 4 hours post dose

• Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose

  Baseline to 6 hours post dose

Study Arms (2)

XPF-001

EXPERIMENTAL

Drug: XPF-001

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

XPF-001 DRUG

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

XPF-001

placebo DRUG

Single oral administration of 5 x 100 mg Placebo capsules.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This model is best suited for drugs with rapid onset of action (e.g. NSAIDs). XPF-001 does not have a rapid onset.

Results Point of Contact

• Title: Vice President Clinical
• Organization: Xenon Pharmaceuticals Inc.

pgoldberg@xenon-pharma.com

6044843300

Study Officials

• Steven Christensen, DDS

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: August 7, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 16, 2012
• Results First Posted: June 29, 2012

Record last verified: 2012-07

Locations

US (1)