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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapentadol intravenous | Experimental | 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. |
|
| Matching placebo intravenous | Placebo Comparator | Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol | Drug | 30 mg per administration, maximum 12 administrations over 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline value; up to 24 hours after first study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
177 participants signed informed consent.
The recruitment period for this trial was from the 26 September 2011 and was completed on the 14 Feb 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tapentadol Intravenous | 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. 64 Participants Randomized, 64 Participants in the Safety Set (SAF), 64 Participants in the Full Analysis Set (FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment. |
| FG001 | Matching Placebo Intravenous | Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain. 65 Randomized participants, 65 Participants in the Safety Set (SAF), 65 Participants in the Full Analysis Set(FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tapentadol Intravenous | 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. |
| BG001 | Matching Placebo Intravenous |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline value; up to 24 hours after first study drug administration |
|
From administration of first dose of study drug up to 4 days after the administration of the last dose of study drug.
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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 | Tapentadol Intravenous | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Grünenthal GmbH | +241 569 3223 |
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| ID | Term |
|---|---|
| D000071378 | Bunion |
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Matching Placebo | Drug | Maximum 12 administrations over 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. | 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). | 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). | 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). | 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. | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline; for the first 6 administrations |
| Alternative treatment started |
|
Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline pain intensity | Pain intensity assessed prior to the first administration of study medication. Pain intensity is assessed by the participant 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". | Mean | Standard Deviation | units on a scale |
|
| Tapentadol Intravenous |
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. |
| OG001 | Matching Placebo Intravenous | Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain. |
|
|
| Secondary | 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. | Full Analysis Set (FAS). Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake. | Posted | Mean | Standard Deviation | units on a scale | Baseline; up to 48 hours |
|
|
|
| Secondary | 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. | Full Analysis Set (FAS): Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake. | Posted | Mean | Standard Deviation | units on a scale | Starting at 15 minutes and up to 48 hours after first drug administration |
|
|
|
| Secondary | 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). | Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point. | Posted | Number | participants | Baseline value to 12 hours after first study drug administration |
|
|
|
| Secondary | 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). | Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point. | Posted | Number | participants | Baseline value to 24 hours after study drug administration |
|
|
|
| Secondary | 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). | Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point. | Posted | Number | participants | Baseline value to 48 hours after first study drug administration |
|
|
|
| Secondary | 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. | Full analysis set. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline value to 60 minutes after first study drug administration |
|
|
|
| Secondary | 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). | Full analysis set. Primary imputation method was analyzed: Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 h after each rescue medication intake. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline value to 4 hours after first study drug intake |
|
|
|
| Secondary | 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). | Full Analysis Set. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline value to 8 hours after first study drug administration |
|
|
|
| Secondary | 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). | Full Analysis Set. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline value to 12 hours after first study drug administration |
|
|
|
| Secondary | 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). | Full Analysis Set. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline value to 48 hours after first study drug administration |
|
|
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| Secondary | 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. | Full analysis set. | Posted | Number | participants | Baseline value to 12 hours after first study drug administration |
|
|
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| Secondary | 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. | Full analysis set. | Posted | Number | participants | Baseline value to 24 hours after first study drug administration |
|
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| Secondary | 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. | Full analysis set. | Posted | Number | participants | Baseline value to 48 hours after first study drug administration |
|
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| Secondary | 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. | Full analysis set. | Posted | Number | participants | Baseline value to 12 hours after first study drug administration |
|
|
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| Secondary | 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. | Full analysis set. | Posted | Number | participants | Baseline value to 24 hours after first study drug administration |
|
|
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| Secondary | 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. | Full analysis set. | Posted | Number | participants | Baseline value to 48 hours after first study drug administration |
|
|
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| Secondary | Time to First Rescue Medication | The median time to first rescue medication intake (600 mg ibuprofen) in hours. | Full analysis set. | Posted | Median | 95% Confidence Interval | hours | up to 48 hours |
|
|
|
| Secondary | 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. | Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time to perceptible pain relief is not reported for matching placebo arms because of the high number of discontinuations. | Posted | Median | 95% Confidence Interval | hours | up to 48 hours |
|
|
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| Secondary | 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. | Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time in hours to meaningful pain relief are not reported for matching placebo arm due to the high discontinuation rate. | Posted | Median | 95% Confidence Interval | hours | up to 48 hours |
|
|
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| Secondary | 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. | Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis. | Posted | Mean | Full Range | ng/mL | 15 minutes to 20 hours after first drug administration |
|
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| Post-Hoc | Number of Participants Scored as a Responder Based on Patient Global Impression of Change | 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 with early second dose the PGIC assessment from End-of-double-blind Treatment was taken as the 48 hours value. Assessments done more than 4.5 hours after the 12th infusion were excluded from analysis and participants were considered non-responders. | Posted | Number | participants | Fixed time points at 12, 24 and 48 hours after baseline |
|
|
|
| Secondary | 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. | Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis. | Posted | Mean | Full Range | ng/mL | 15 minutes to 20 hours after first drug administration |
|
|
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| Secondary | 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. | Participants contributing data. | Posted | Mean | Standard Deviation | units on a scale | Baseline; for the first 6 administrations |
|
|
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| Secondary | 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. | Participants contributing data (indicated in brackets) | Posted | Mean | Standard Deviation | units on a scale | Baseline; for the first 6 administrations |
|
|
|
| 0 |
| 64 |
| 63 |
| 64 |
| EG001 | Matching Placebo Intravenous | Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain. | 0 | 65 | 37 | 65 |
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Infusion site phlebitis | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Injection site phlebitis | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nystagmus | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pharyngeal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pyuria | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tongue injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
The sponsor reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| 0.5 hour after first dose |
|
| 1 hour after first dose |
|
| 2 hours after first dose |
|
| 4 hours after first dose |
|
| 6 hours after first dose |
|
| 8 hours after first dose |
|
| 12 hours after first dose |
|
| 16 hours after first dose |
|
| 20 hours after first dose |
|
| 24 hours after first dose |
|
| 36 hours after first dose |
|
| 48 hours after first dose |
|
| 1 hour after first administration |
|
| 2 hours after first administration |
|
| 4 hours after first dose administration |
|
| 6 hours after first dose administration |
|
| 8 hours after first dose administration |
|
| 12 hours after first dose administration |
|
| 16 hours after first dose administration |
|
| 20 hours after first dose administration |
|
| 24 hours after first dose administration |
|
| 36 hours after first dose administration |
|
| 48 hours after first dose administration |
|
| Minimally Improved |
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Minimally Improved |
|
| No Change |
|
| Minimally Worse |
|
| Minimally Improved |
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
|
| 60 minutes after first infusion |
|
|
| 4 hours after end of first infusion |
|
|
| 3.5 hours after end of fifth infusion |
|
|
| 4 hours after end of fifth infusion |
|
|
| Responders 48 hours after first dose |
|
|
| 60 minutes after first infusion |
|
|
| 4 hours after end of first infusion |
|
|
| 3.5 hours after end of fifth infusion |
|
|
| 4 hours after end of fifth infusion |
|
|
|
| prior to second dose |
|
|
| 1 hour after second dose |
|
|
| prior to third dose |
|
|
| 1 hour after third dose |
|
|
| prior to fourth dose |
|
|
| 1 hour after fourth dose |
|
|
| prior to fifth dose |
|
|
| 1 hour after fifth dose |
|
|
| prior to sixth dose |
|
|
|
| prior to second dose |
|
|
| 1 hour after second dose |
|
|
| prior to third dose |
|
|
| 1 hour after third dose |
|
|
| prior to fourth dose |
|
|
| 1 hour after fourth dose |
|
|
| prior to fifth dose |
|
|
| 1 hour after fifth dose |
|
|
| prior to sixth dose |
|
|
| 1 hour after sixth dose |
|
|