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Intravenous Tapentadol in Post-Bunionectomy Pain

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ClinicalTrials.gov Identifier: NCT01435577
Recruitment Status : Completed
First Posted : September 16, 2011
Results First Posted : June 24, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH

Tracking Information
First Submitted Date  ICMJE September 15, 2011
First Posted Date  ICMJE September 16, 2011
Results First Submitted Date  ICMJE March 5, 2013
Results First Posted Date  ICMJE June 24, 2013
Last Update Posted Date July 2, 2013
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2013)
Sum of Pain Intensity Differences (SPID 24) [ Time Frame: Baseline value; up to 24 hours after first study drug administration ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2011)
Sum of Pain Intensity Differences (SPID 24) [ Time Frame: Baseline value to 24 hours after first study drug intake ]
Pain Intensity assessed at predefined time points 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". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain).
Change History Complete list of historical versions of study NCT01435577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
  • Mean Pain Intensity Scores at Fixed Time Points [ Time Frame: Baseline; up to 48 hours ]
    The mean pain intensity at fixed time points in the trial for all participants is listed. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
  • Pain Intensity Differences at Fixed Time Points [ Time Frame: Starting at 15 minutes and up to 48 hours after first drug administration ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline pain intensity (prior to the first dose) and the pain intensity at the time. A negative number indicates a decrease in pain in the whole treatment group. The greater the negative pain intensity difference value the greater the pain relief in the treatment arm. A score of 0 indicates that there has been no change in pain in a treatment group. A positive value indicates an increase in pain in the treatment group.
  • Patient Global Impression of Change After 12 Hours of Treatment [ Time Frame: Baseline value to 12 hours after first study drug administration ]
    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
  • Patients Global Impression of Change After 24 Hours of Treatment [ Time Frame: Baseline value to 24 hours after study drug administration ]
    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
  • Patient Global Impression of Change After 48 Hours of Treatment [ Time Frame: Baseline value to 48 hours after first study drug administration ]
    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
  • Sum of Pain Intensity Differences After 60 Minutes [ Time Frame: Baseline value to 60 minutes after first study drug administration ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the value is negative then the baseline pain intensity was greater than the pain intensity measured after dosing.
  • Sum of Pain Intensity Differences After 4 Hours [ Time Frame: Baseline value to 4 hours after first study drug intake ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 4 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
  • Sum of Pain Intensity Differences After 8 Hours [ Time Frame: Baseline value to 8 hours after first study drug administration ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 8 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
  • Sum of Pain Intensity Differences After 12 Hours [ Time Frame: Baseline value to 12 hours after first study drug administration ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 12 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
  • Sum of Pain Intensity Differences After 48 Hours [ Time Frame: Baseline value to 48 hours after first study drug administration ]
    Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).
  • Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores [ Time Frame: Baseline value to 12 hours after first study drug administration ]
    Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
  • Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores [ Time Frame: Baseline value to 24 hours after first study drug administration ]
    Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
  • Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores [ Time Frame: Baseline value to 48 hours after first study drug administration ]
    Individual participants response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.
  • Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores [ Time Frame: Baseline value to 12 hours after first study drug administration ]
    Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
  • Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores [ Time Frame: Baseline value to 24 hours after first study drug administration ]
    Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
  • Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores [ Time Frame: Baseline value to 48 hours after first study drug administration ]
    Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.
  • Time to First Rescue Medication [ Time Frame: up to 48 hours ]
    The median time to first rescue medication intake (600 mg ibuprofen) in hours.
  • Time to Perceptible Pain Relief [ Time Frame: up to 48 hours ]
    When the participant began to feel any pain-relieving effect after the administration of the first dose they were requested to stop the first stopwatch. The time was noted. This measured when the participant first felt any difference in the pain.
  • Time to Meaningful Pain Relief [ Time Frame: up to 48 hours ]
    The participant was instructed to stop the stopwatch when they had meaningful pain relief. That is, when the pain relief made a real difference, after the first drug administration.
  • Pharmacokinetic Concentrations of Tapentadol [ Time Frame: 15 minutes to 20 hours after first drug administration ]
    Tapentadol concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
  • Pharmacokinetic Concentrations of Tapentadol-O-glucuronide [ Time Frame: 15 minutes to 20 hours after first drug administration ]
    Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as "breakdown products". The body alters the administered medication to a metabolite so that can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
  • Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants [ Time Frame: Baseline; for the first 6 administrations ]
    The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.
  • Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants [ Time Frame: Baseline; for the first 6 administrations ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2011)
  • Patients Global Impression of Change [ Time Frame: Baseline value to 24 hours after study drug intake ]
    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
  • Sum of Pain Intensity Difference [ Time Frame: Baseline value to 48 hours after study drug intake. ]
    Pain Intensity assessed at predefined time points over a 48 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". Differences calculated as [baseline-post baseline] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Tapentadol in Post-Bunionectomy Pain
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bunion
  • Pain
Intervention  ICMJE
  • Drug: Tapentadol
    30 mg per administration, maximum 12 administrations over 48 hours
    Other Name: Palexia, Nucynta
  • Drug: Matching Placebo
    Maximum 12 administrations over 48 hours
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Tapentadol
  • Placebo Comparator: Matching placebo intravenous
    Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
    Intervention: Drug: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2012)
177
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2011)
128
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01435577
Other Study ID Numbers  ICMJE 295054
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grünenthal GmbH
Study Sponsor  ICMJE Grünenthal GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Grünenthal GmbH
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP