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The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XPF-001 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XPF-001 | Drug | Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Christensen, DDS | Jean Brown Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
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All 61 subjects were recruited at a single center between September 29th and November 16th 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | XPF-001 | 500 mg XEN402 (5x 100 mg capsules) administered as a single dose |
| FG001 | Placebo | 5 x matching placebo capsules (administered as a single dose) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XPF-001 | 500 mg XEN402 (5x 100 mg capsules) administered as a single dose |
| BG001 | Placebo | 5 x matching placebo capsules (administered as a single dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Published data from an impacted wisdom tooth removal was used to determine a 60 subject study with 2:1 randomisation and a one-sided significance level of 0.10 would have a power of 84.1%. LOCF was used for imputed values and all subjects were included in both the IIT and PP populations for analysis. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6 hours post dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XPF-001 | 500 mg XEN402 (5x 100 mg capsules) administered as a single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
This model is best suited for drugs with rapid onset of action (e.g. NSAIDs). XPF-001 does not have a rapid onset.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical | Xenon Pharmaceuticals Inc. | 6044843300 | pgoldberg@xenon-pharma.com |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| placebo |
| Drug |
Single oral administration of 5 x 100 mg Placebo capsules. |
|
| 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 | 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. | 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. | 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. | 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. | 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. | 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). | 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'. | 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. | 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). | 48 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction. |
| OG001 | XPF-001 | Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction. |
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| Secondary | 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). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 4 hours |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 hours |
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| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 12 hours |
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| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 4 hours post dose |
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| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 6 hours post dose |
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| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 8 hours post dose |
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| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 12 hours post dose |
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| Secondary | 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). | Posted | Median | 95% Confidence Interval | Minutes | 24 hours |
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| Secondary | 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'. | Posted | Median | 90% Confidence Interval | Minutes | 24 hours |
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| Secondary | 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. | Posted | Median | 95% Confidence Interval | Minutes | 24 hours |
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| Secondary | 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). | Posted | Number | Events | 48 hours |
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| 0 |
| 41 |
| 16 |
| 41 |
| EG001 | Placebo | 5 x matching placebo capsules (administered as a single dose) | 0 | 20 | 4 | 20 |
| Somnolence | Nervous system disorders |
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| Nausea | Gastrointestinal disorders |
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| Neutrophil count increased | Investigations |
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| White blood cell count increased | Investigations |
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| Confusional State | Psychiatric disorders |
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| Headache | Nervous system disorders |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |