The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
106
One 600 mg caplet dosed at 0, 12, 24 and 36 hours
One placebo caplet dosed at times 0, 12, 24 and 36 hours
Central Texas Oral Surgery Associates
Austin, Texas, United States
Premier Research
Austin, Texas, United States
Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)
SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \[=\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.
Time frame: Baseline to 12 hours
Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose
SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy.
Time frame: 8 to 12 hours
Time-weighted Sum of Pain Intensity Difference (SPID) Scores
SPID is a derived endpoint from PID scores. For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity.
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Time frame: 0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours
Time to First Dose of Rescue Medication After First Dose of Study Drug
During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded.
Time frame: Baseline to 12 hours
Percentage of Participants Taking Rescue Medication
Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval.
Time frame: Baseline to 48 hours
Pain Relief (PR) Scores
A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: "How much relief do you have from your starting pain?" Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief.
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours
Pain Intensity Difference (PID) Scores
For pain intensity, "How much pain do you have at this time?" answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity).
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours
Pain Relief Combined With Pain Intensity (PRID) Scores
PRID score=PR plus PID. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity.
Time frame: 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours
Time-weighted Sum of Pain Relief Scores (TOTPAR)
TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best).
Time frame: 0-12 hours, 8-12 hours
Number of Doses of Rescue Medication Used
Time frame: 0-12, 12-24, 24-36, 36-48, 0-48 hours
Time to Confirmed First Perceptible Relief
The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling.
Time frame: Baseline to 12 hours
Time to Meaningful Relief
Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant.
Time frame: Baseline to 12 hours
Participant Global Evaluation Score
Participants responded, on a 6-point categorical scale, to the following question: "How would you rate this medication as a pain-reliever?" Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.
Time frame: 24 and 48 hours