Skip to main content
OpenTrials
Completed

NCT Number: NCT01435577

Intravenous Tapentadol in Post-Bunionectomy Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bunion Acute Pain Foot Deformities Foot Deformities, Acquired Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tapentadol

Drug

30 mg per administration, maximum 12 administrations over 48 hours

Other names: Palexia, Nucynta

Matching Placebo

Drug

Maximum 12 administrations over 48 hours

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Time to First Rescue Medication

    Time frame: up to 48 hours

    The median time to first rescue medication intake (600 mg ibuprofen) in hours.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

Sponsors and collaborators

Lead sponsor

Grünenthal GmbH

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2011
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.