Back to resultsIntravenous Tapentadol in Post-Bunionectomy Pain
Primary Purpose
Bunion, Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tapentadol
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bunion focused on measuring Bunionectomy, Postsurgical Pain, Acute Pain
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo primary unilateral first metatarsal bunionectomy
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
- Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).
Exclusion Criteria:
- History of malignancy within the past 2 years
- Current or history of alcohol or drug abuse.
- Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
- History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
- Severely impaired renal function
- Moderately or severely impaired hepatic function
- Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
- Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication
Sites / Locations
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tapentadol intravenous
Matching placebo intravenous
Arm Description
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.
Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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).
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).
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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 to First Rescue Medication
The median time to first rescue medication intake (600 mg ibuprofen) in 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 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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01435577
Brief Title
Intravenous Tapentadol in Post-Bunionectomy Pain
Official Title
A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bunion, Pain
Keywords
Bunionectomy, Postsurgical Pain, Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tapentadol intravenous
Arm Type
Experimental
Arm Description
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.
Arm Title
Matching placebo intravenous
Arm Type
Placebo Comparator
Arm Description
Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
Intervention Type
Drug
Intervention Name(s)
Tapentadol
Other Intervention Name(s)
Palexia, Nucynta
Intervention Description
30 mg per administration, maximum 12 administrations over 48 hours
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Maximum 12 administrations over 48 hours
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Differences (SPID 24)
Description
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
Secondary Outcome Measure Information:
Title
Mean Pain Intensity Scores at Fixed Time Points
Description
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
Title
Pain Intensity Differences at Fixed Time Points
Description
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
Title
Patient Global Impression of Change After 12 Hours of Treatment
Description
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
Title
Patients Global Impression of Change After 24 Hours of Treatment
Description
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
Title
Patient Global Impression of Change After 48 Hours of Treatment
Description
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
Title
Sum of Pain Intensity Differences After 60 Minutes
Description
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
Title
Sum of Pain Intensity Differences After 4 Hours
Description
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
Title
Sum of Pain Intensity Differences After 8 Hours
Description
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
Title
Sum of Pain Intensity Differences After 12 Hours
Description
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
Title
Sum of Pain Intensity Differences After 48 Hours
Description
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
Title
Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores
Description
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
Title
Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores
Description
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
Title
Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores
Description
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
Title
Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores
Description
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
Title
Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores
Description
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
Title
Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores
Description
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
Title
Time to First Rescue Medication
Description
The median time to first rescue medication intake (600 mg ibuprofen) in hours.
Time Frame
up to 48 hours
Title
Time to Perceptible Pain Relief
Description
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
Title
Time to Meaningful Pain Relief
Description
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
Title
Pharmacokinetic Concentrations of Tapentadol
Description
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
Title
Pharmacokinetic Concentrations of Tapentadol-O-glucuronide
Description
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
Title
Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants
Description
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
Title
Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo primary unilateral first metatarsal bunionectomy
Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).
Exclusion Criteria:
History of malignancy within the past 2 years
Current or history of alcohol or drug abuse.
Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
Severely impaired renal function
Moderately or severely impaired hepatic function
Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
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Intravenous Tapentadol in Post-Bunionectomy Pain
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