A Phase 2 interventional study of Tapentadol and Matching Placebo in Bunion and Pain, sponsored by Grünenthal GmbH. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-28.
Sponsored by Grünenthal GmbH · Phase 2, Interventional, and Treatment
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
86 studies on the registry are indexed under Bunion; 13 are open to participants now.
This study's enrollment of 177 is above the median of 60 across 64 interventional studies indexed under Bunion.
Browse Bunion studies →Grünenthal GmbH is the lead sponsor of 68 studies on the registry; 2 are open to participants now.
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Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
Drug: Tapentadol
Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
Drug: Matching Placebo
30 mg per administration, maximum 12 administrations over 48 hours
Also known as: Palexia, Nucynta
Maximum 12 administrations over 48 hours
Sum of Pain Intensity Differences (SPID 24)
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.
Time frame: Baseline value; up to 24 hours after first study drug administration
Mean Pain Intensity Scores at Fixed Time Points
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.
Time frame: Baseline; up to 48 hours
Pain Intensity Differences at Fixed Time Points
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.
Time frame: Starting at 15 minutes and up to 48 hours after first drug administration
Patient Global Impression of Change After 12 Hours of Treatment
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).
Time frame: Baseline value to 12 hours after first study drug administration
Patients Global Impression of Change After 24 Hours of Treatment
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).
Time frame: Baseline value to 24 hours after study drug administration
Patient Global Impression of Change After 48 Hours of Treatment
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).
Time frame: Baseline value to 48 hours after first study drug administration
Sum of Pain Intensity Differences After 60 Minutes
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.
Time frame: Baseline value to 60 minutes after first study drug administration
Sum of Pain Intensity Differences After 4 Hours
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).
Time frame: Baseline value to 4 hours after first study drug intake
Sum of Pain Intensity Differences After 8 Hours
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).
Time frame: Baseline value to 8 hours after first study drug administration
Sum of Pain Intensity Differences After 12 Hours
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).
Time frame: Baseline value to 12 hours after first study drug administration
Sum of Pain Intensity Differences After 48 Hours
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).
Time frame: Baseline value to 48 hours after first study drug administration
Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores
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.
Time frame: Baseline value to 12 hours after first study drug administration
Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores
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.
Time frame: Baseline value to 24 hours after first study drug administration
Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores
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.
Time frame: Baseline value to 48 hours after first study drug administration
Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores
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.
Time frame: Baseline value to 12 hours after first study drug administration
Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores
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.
Time frame: Baseline value to 24 hours after first study drug administration
Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores
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 frame: Baseline value to 48 hours after first study drug administration
Time to First Rescue Medication
The median time to first rescue medication intake (600 mg ibuprofen) in hours.
Time frame: up to 48 hours
Time to Perceptible Pain Relief
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 frame: up to 48 hours
Time to Meaningful Pain Relief
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.
Time frame: up to 48 hours
Pharmacokinetic Concentrations of Tapentadol
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.
Time frame: 15 minutes to 20 hours after first drug administration
Pharmacokinetic Concentrations of Tapentadol-O-glucuronide
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.
Time frame: 15 minutes to 20 hours after first drug administration
Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants
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.
Time frame: Baseline; for the first 6 administrations
Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants
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.
Time frame: Baseline; for the first 6 administrations
The recruitment period for this trial was from the 26 September 2011 and was completed on the 14 Feb 2012.
| Milestone | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Started | 64 | 65 |
| Completed | 47 | 13 |
| Not completed | 17 | 52 |
| Withdrew: Adverse event | 10 | 0 |
| Withdrew: Lack of efficacy | 7 | 51 |
| Withdrew: Alternative treatment started | 0 | 1 |
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.
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Sum of Pain Intensity Differences (SPID 24) | -51.23 (-59.93 to -42.52) | 25.46 (16.82 to 34.10) |
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.
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Baseline (before first study drug administration) | 7.2 ± 1.41 | 7.3 ± 1.54 |
| 0.25 hours after first dose | 3.7 ± 1.99 | 7.1 ± 1.57 |
| 0.5 hour after first dose | 3.1 ± 1.77 | 7.4 ± 1.63 |
| 1 hour after first dose | 3.6 ± 1.77 | 7.8 ± 1.76 |
| 2 hours after first dose | 5.8 ± 2.03 | 8.5 ± 1.5 |
| 4 hours after first dose | 6.1 ± 1.92 | 8.6 ± 1.46 |
| 6 hours after first dose | 6.3 ± 2.25 | 8.7 ± 1.47 |
| 8 hours after first dose | 6.5 ± 2.29 | 8.6 ± 1.61 |
| 12 hours after first dose | 5.2 ± 2.7 | 8.5 ± 1.67 |
| 16 hours after first dose | 3.8 ± 2.58 | 8.2 ± 2.12 |
| 20 hours after first dose | 3.7 ± 2.52 | 8.0 ± 2.24 |
| 24 hours after first dose | 4.1 ± 2.43 | 8.1 ± 2.08 |
| 36 hours after first dose | 3.9 ± 2.49 | 8.0 ± 2.39 |
| 48 hours after first dose | 4.3 ± 2.56 | 8.1 ± 2.21 |
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.
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| 0.25 hours after first administration | -3.5 ± 2.22 | -0.2 ± 0.95 |
| 0.5 hours after first administration | -4.1 ± 2.24 | 0.1 ± 1.18 |
| 1 hour after first administration | -3.5 ± 2.07 | 0.5 ± 1.4 |
| 2 hours after first administration | -1.3 ± 2.24 | 1.2 ± 1.39 |
| 4 hours after first dose administration | -1.0 ± 2.09 | 1.4 ± 1.47 |
| 6 hours after first dose administration | -0.9 ± 2.32 | 1.4 ± 1.51 |
| 8 hours after first dose administration | -0.7 ± 2.5 | 1.3 ± 1.58 |
| 12 hours after first dose administration | -2.0 ± 3.01 | 1.2 ± 1.57 |
| 16 hours after first dose administration | -3.4 ± 2.90 | 0.9 ± 1.82 |
| 20 hours after first dose administration | -3.5 ± 2.89 | 0.7 ± 2.08 |
| 24 hours after first dose administration | -3.1 ± 2.65 | 0.9 ± 2.0 |
| 36 hours after first dose administration | -3.2 ± 2.68 | 0.8 ± 2.26 |
| 48 hours after first dose administration | -2.9 ± 2.76 | 0.8 ± 2.11 |
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).
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Very Much Improved | 11 | 0 |
| Much Improved | 20 | 1 |
| Minimally Improved | 14 | 9 |
| No Change | 5 | 4 |
| Minimally Worse | 4 | 1 |
| Much Worse | 0 | 0 |
| Very Much Worse | 0 | 0 |
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).
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Very Much Improved | 13 | 0 |
| Much Improved | 26 | 5 |
| Minimally Improved | 11 | 6 |
| No Change | 1 | 2 |
| Minimally Worse | 1 | 2 |
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).
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Very Much Improved | 19 | 2 |
| Much Improved | 24 | 8 |
| Minimally Improved | 4 | 2 |
| No Change | 0 | 1 |
| Minimally Worse | 0 | 0 |
| Much Worse | 0 | 0 |
| Very Much Worse | 0 | 0 |
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.
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Sum of Pain Intensity Differences After 60 Minutes | -3.65 (-4.01 to -3.3) | 0.26 (-0.10 to 0.61) |
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).
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Sum of Pain Intensity Differences After 4 Hours | -6.76 (-7.92 to -5.61) | 4.22 (3.07 to 5.37) |
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).
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Sum of Pain Intensity Differences After 8 Hours | -9.9 (-12.5 to -7.31) | 9.74 (7.17 to 12.32) |
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).
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Sum of Pain Intensity Differences After 12 Hours | -14.98 (-19.09 to -10.87) | 14.82 (10.74 to 18.90) |
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).
| units on a scale | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Sum of Pain Intensity Differences After 48 Hours | -122.93 (-143.73 to -102.13) | 45.86 (25.22 to 66.5) |
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.
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores | 27 | 1 |
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.
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores | 31 | 4 |
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.
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores | 8 | 1 |
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.
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores | 18 | 1 |
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.
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores | 24 | 1 |
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.
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores | 6 | 0 |
The median time to first rescue medication intake (600 mg ibuprofen) in hours.
| hours | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Time to First Rescue Medication | 5.4 (4.7 to 7.1) | 2.1 (1.9 to 2.3) |
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.
| hours | Tapentadol Intravenous |
|---|---|
| Time to Perceptible Pain Relief | 0.2 (0.1 to 0.2) |
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.
| hours | Tapentadol Intravenous |
|---|---|
| Time to Meaningful Pain Relief | 0.3 (0.3 to 0.4) |
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.
| ng/mL | Tapentadol Intravenous |
|---|---|
| 15 minutes after first infusion | 201.2 (69.5 to 593) |
| 30 minutes after first infusion | 99.5 (59.8 to 164) |
| 60 minutes after first infusion | 76.4 (43.3 to 103) |
| 4 hours after end of first infusion | 38.2 (21.5 to 60.5) |
| 3.5 hours after end of fifth infusion | 73.2 (39.4 to 106) |
| 4 hours after end of fifth infusion | 70.3 (34.4 to 105) |
Responders are those participants with Patient Global Impression of Change (PGIC) values "Much improved", or "Very much improved". Participants with missing value are considered non-responders.
| participants | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| Responders 12 hours after first dose | 31 | 1 |
| Responders 24 hours after first dose | 39 | 5 |
| Responders 48 hours after first dose | 43 | 10 |
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.
| ng/mL | Tapentadol Intravenous |
|---|---|
| 15 minutes after first infusion | 26.4 (11.6 to 88.2) |
| 30 minutes after first infusion | 290.4 (111 to 515) |
| 60 minutes after first infusion | 488.2 (287 to 666) |
| 4 hours after end of first infusion | 452.4 (265 to 651) |
| 3.5 hours after end of fifth infusion | 1048.7 (680 to 1410) |
| 4 hours after end of fifth infusion | 945.1 (608 to 1200) |
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.
| units on a scale | Tapentadol Intravenous |
|---|---|
| Prior to first dose (n = 64) | 7.2 ± 1.41 |
| 1 hour after first dose (n = 64) | 3.6 ± 1.77 |
| prior to second dose | 7.3 ± 1.59 |
| 1 hour after second dose | 4.7 ± 2.09 |
| prior to third dose | 7.2 ± 1.6 |
| 1 hour after third dose | 6.1 ± 2.71 |
| prior to fourth dose | 6.6 ± 2.21 |
| 1 hour after fourth dose | 4.1 ± 2.96 |
| prior to fifth dose | 4.9 ± 2.57 |
| 1 hour after fifth dose | 2.7 ± 2.47 |
| prior to sixth dose | 4.5 ± 2.35 |
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.
| units on a scale | Matching Placebo Intravenous |
|---|---|
| Prior to first dose | 7.3 ± 1.54 |
| 1 hour after first dose | 7.8 ± 1.76 |
| prior to second dose | 8.4 ± 1.30 |
| 1 hour after second dose | 8.6 ± 1.53 |
| prior to third dose | 7.9 ± 1.65 |
| 1 hour after third dose | 7.9 ± 1.77 |
| prior to fourth dose | 7.3 ± 2.05 |
| 1 hour after fourth dose | 7.1 ± 2.07 |
| prior to fifth dose | 5.8 ± 2.04 |
| 1 hour after fifth dose | 5.2 ± 2.24 |
| prior to sixth dose | 5.7 ± 2.13 |
| 1 hour after sixth dose | 4.8 ± 1.76 |
Collected over From administration of first dose of study drug up to 4 days after the administration of the last dose of study drug.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tapentadol Intravenous | — | 0/64 (0%) | 63/64 (98.4%) |
| Matching Placebo Intravenous | — | 0/65 (0%) | 37/65 (56.9%) |
| Event | Tapentadol Intravenous | Matching Placebo Intravenous |
|---|---|---|
| NauseaGastrointestinal disorders | 43/64 | 27/65 |
| VomitingGastrointestinal disorders | 29/64 | 11/65 |
| SomnolenceNervous system disorders | 27/64 | 2/65 |
| DizzinessNervous system disorders | 25/64 | 8/65 |
| Feeling hotGeneral disorders | 13/64 | 1/65 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 11/64 | 2/65 |
| Oxygen saturation decreasedInvestigations | 11/64 | 0/65 |
| PruritusSkin and subcutaneous tissue disorders | 10/64 | 4/65 |
| HeadacheNervous system disorders | 9/64 | 2/65 |
| Infusion site phlebitisGeneral disorders | 9/64 | 0/65 |
The summary statistics provided for baseline was based on safety population that included 64 subjects in the tapentadol group and 65 in the placebo group. The safety population includes randomized participants that received at least one dose of study drug.
| Age, Continuous(years) | Tapentadol Intravenous | Matching Placebo Intravenous | Total |
|---|---|---|---|
| Mean | 41.2 ± 12.61 | 35.8 ± 12.41 | 38.5 ± 12.75 |
| Sex: Female, Male(Participants) | Tapentadol Intravenous | Matching Placebo Intravenous | Total |
|---|---|---|---|
| Female | 57 | 60 | 117 |
| Male | 7 | 5 | 12 |
| Region of Enrollment(participants) | Tapentadol Intravenous | Matching Placebo Intravenous | Total |
|---|---|---|---|
| United States | 64 | 65 | 129 |
| Baseline pain intensity(units on a scale) | Tapentadol Intravenous | Matching Placebo Intravenous | Total |
|---|---|---|---|
| Mean | 7.2 ± 1.41 | 7.3 ± 1.54 | 7.2 ± 1.47 |
The record gives a start of Sep 2011, a primary completion of Feb 2012 and a completion of Feb 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2013, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tapentadol