Dental PainPhase 2NCT00954356
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
A Phase 2 study testing XPF-001 in people with Dental Pain, run by Xenon Pharmaceuticals Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pain
- What is being tested?
- XPF-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- XPF-001, placebo
- Keywords
- Pain following 3rd molar/wisdom tooth extraction
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPF-001Drug
Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules)
placeboDrug
Single oral administration of 5 x 100 mg Placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| XPF-001 | Experimental | Not described Receives: Drug: XPF-001 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours post dose
Secondary outcomes (11)
Total Pain Relief (TOTPAR) at 4 Hours Post Dose
A secondary efficacy variable was total pain relief at the 4-hour observation (TOTPAR 4); TOTPAR 4 is an area calculation incorporating time and relief scores over the 4 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 4 score = 0, maximum possible score = 16).
Measured: 4 hours
Total Pain Relief (TOTPAR) at 8 Hours Post Dose
A secondary efficacy variable was total pain relief at the 8-hour observation (TOTPAR 8); TOTPAR 8 is an area calculation incorporating time and relief scores over the 8 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 8 score = 0, maximum possible score = 32
Measured: 8 hours
Total Pain Relief (TOTPAR) at 12 Hours Post Dose
A secondary efficacy variable was total pain relief at the 12-hour observation (TOTPAR 12); TOTPAR 12 is an area calculation incorporating time and relief scores over the 12 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 12 score = 0, maximum possible score = 48.
Measured: 12 hours
Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose
Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID4 is an area calculation encompassing time and the PID scores over the 4 hours following dosing. The minimum possible SPID4 value = -40, the maximum possible = 40.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period.
Measured: Baseline to 4 hours post dose
Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose
Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID6 is an area calculation encompassing time and the PID scores over the 6 hours following dosing. The minimum possible SPID6 value = -60, the maximum possible = 60.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period.
Measured: Baseline to 6 hours post dose
Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose
Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID8 is an area calculation encompassing time and the PID scores over the 8 hours following dosing. The minimum possible SPID8 value = -80, the maximum possible = 80.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period.
Measured: Baseline to 8 hours post dose
Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose
Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).
SPID12 is an area calculation encompassing time and the PID scores over the 12 hours following dosing. The minimum possible SPID12 value = -120, the maximum possible = 120.
A positive SPID LS Means score implies reduced pain intensity over the corresponding time period.
Measured: Baseline to 12 hours post dose
Time to First Perceptible Relief
Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).
Measured: 24 hours
Time to Meaningful Relief
Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).
'Meaningful Relief' was defined as when the relief became 'meaningful' to each individual subject, and was not necessarily a complete absence of pain. 'Meaningful Relief' could not occur before 'First Perceptible Relief'.
Measured: 24 hours
Time to Rescue Medication
The time of administration of rescue medication (if any) was recorded for each subject and the duration since dosing was calculated.
Measured: 24 hours
Treatment Emergent Adverse Events
Adverse Events were recorded at the time of occurence. Clinically significant findings (if any) in ECG and vital signs assessments and laboratory samples were recorded as adverse events.
Treatment Emergent Adverse Events (TEAEs) are those which either started or worsened following administration of study drug (XPF-001 or placebo).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Christensen, DDS, Principal investigator, Jean Brown Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954356
- Sponsor's protocol ID
- XPF-001-201
- Status last verified
- Jul 2012
- First submitted
- 22 Jul 2009
- Last updated
- 16 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00954356
- Acronym / sponsor ID
- XPF-001-201
- Conditions
- Dental Pain
- Keywords
- Pain following 3rd molar/wisdom tooth extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Posted 29 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XPF-001 | Experimental | Drug: XPF-001 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPF-001Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules) | Drug | XPF-001 |
| placeboSingle oral administration of 5 x 100 mg Placebo capsules. | Drug | Placebo |
Primary outcome
Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)
Time frame: 6 hours post dose
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
11 secondary outcomes
Total Pain Relief (TOTPAR) at 4 Hours Post Dose
Time frame: 4 hours
Total Pain Relief (TOTPAR) at 8 Hours Post Dose
Time frame: 8 hours
Total Pain Relief (TOTPAR) at 12 Hours Post Dose
Time frame: 12 hours
Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose
Time frame: Baseline to 4 hours post dose
Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose
Time frame: Baseline to 6 hours post dose
Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose
Time frame: Baseline to 8 hours post dose
Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose
Time frame: Baseline to 12 hours post dose
Time to First Perceptible Relief
Time frame: 24 hours
Time to Meaningful Relief
Time frame: 24 hours
Time to Rescue Medication
Time frame: 24 hours
Treatment Emergent Adverse Events
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Christensen, DDS principal investigator
Jean Brown Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XPF-001 in people with Dental Pain, run by Xenon Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pain Relief at 6 Hours Post Dose (TOTPAR 6) (time frame: 6 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.