| Current Primary Outcome Measures | Sum of Pain Intensity Differences (SPID 24) [Time Frame: Baseline value; up to 24 hours after first study drug administration] [Designated as safety issue: No]Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline. |
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| Current Secondary Outcome Measures | - Mean Pain Intensity Scores at Fixed Time Points [Time Frame: Baseline; up to 48 hours] [Designated as safety issue: No]The mean pain intensity at fixed time points in the trial for all participants is listed. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
- Pain Intensity Differences at Fixed Time Points [Time Frame: Starting at 15 minutes and up to 48 hours after first drug administration] [Designated as safety issue: No]Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline pain intensity (prior to the first dose) and the pain intensity at the time. A negative number indicates a decrease in pain in the whole treatment group. The greater the negative pain intensity difference value the greater the pain relief in the treatment arm. A score of 0 indicates that there has been no change in pain in a treatment group. A positive value indicates an increase in pain in the treatment group.
- Patient Global Impression of Change After 12 Hours of Treatment [Time Frame: Baseline value to 12 hours after first study drug administration] [Designated as safety issue: No]In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
- Patients Global Impression of Change After 24 Hours of Treatment [Time Frame: Baseline value to 24 hours after study drug administration] [Designated as safety issue: No]In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
- Patient Global Impression of Change After 48 Hours of Treatment [Time Frame: Baseline value to 48 hours after first study drug administration] [Designated as safety issue: No]In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
- Sum of Pain Intensity Differences After 60 Minutes [Time Frame: Baseline value to 60 minutes after first study drug administration] [Designated as safety issue: No]Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the value is negative then the baseline pain intensity was greater than the pain intensity measured after dosing.
- Sum of Pain Intensity Differences After 4 Hours [Time Frame: Baseline value to 4 hours after first study drug intake] [Designated as safety issue: No]Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 4 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
- Sum of Pain Intensity Differences After 8 Hours [Time Frame: Baseline value to 8 hours after first study drug administration] [Designated as safety issue: No]Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 8 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
- Sum of Pain Intensity Differences After 12 Hours [Time Frame: Baseline value to 12 hours after first study drug administration] [Designated as safety issue: No]Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 12 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
- Sum of Pain Intensity Differences After 48 Hours [Time Frame: Baseline value to 48 hours after first study drug administration] [Designated as safety issue: No]Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
- Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores [Time Frame: Baseline value to 12 hours after first study drug administration] [Designated as safety issue: No]Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
- Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores [Time Frame: Baseline value to 24 hours after first study drug administration] [Designated as safety issue: No]Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
- Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores [Time Frame: Baseline value to 48 hours after first study drug administration] [Designated as safety issue: No]Individual participants response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
- Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores [Time Frame: Baseline value to 12 hours after first study drug administration] [Designated as safety issue: No]Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
- Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores [Time Frame: Baseline value to 24 hours after first study drug administration] [Designated as safety issue: No]Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
- Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores [Time Frame: Baseline value to 48 hours after first study drug administration] [Designated as safety issue: No]Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
- Time to First Rescue Medication [Time Frame: up to 48 hours] [Designated as safety issue: No]The median time to first rescue medication intake (600 mg ibuprofen) in hours.
- Time to Perceptible Pain Relief [Time Frame: up to 48 hours] [Designated as safety issue: No]When the participant began to feel any pain-relieving effect after the administration of the first dose they were requested to stop the first stopwatch. The time was noted. This measured when the participant first felt any difference in the pain.
- Time to Meaningful Pain Relief [Time Frame: up to 48 hours] [Designated as safety issue: No]The participant was instructed to stop the stopwatch when they had meaningful pain relief. That is, when the pain relief made a real difference, after the first drug administration.
- Pharmacokinetic Concentrations of Tapentadol [Time Frame: 15 minutes to 20 hours after first drug administration] [Designated as safety issue: No]Tapentadol concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
- Pharmacokinetic Concentrations of Tapentadol-O-glucuronide [Time Frame: 15 minutes to 20 hours after first drug administration] [Designated as safety issue: No]Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
- Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants [Time Frame: Baseline; for the first 6 administrations] [Designated as safety issue: No]The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
- Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants [Time Frame: Baseline; for the first 6 administrations] [Designated as safety issue: No]The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
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