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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
Jean Brown Research
Salt Lake City, Utah, United States
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
Time frame: 6 hours post dose
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).
Time frame: 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
Time frame: 8 hours
Total Pain Relief (TOTPAR) at 12 Hours Post Dose
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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'.
Time frame: 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.
Time frame: 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).
Time frame: 48 hours