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A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

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ClinicalTrials.gov Identifier: NCT01516008
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : April 28, 2014
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE January 19, 2012
First Posted Date  ICMJE January 24, 2012
Results First Submitted Date  ICMJE January 24, 2014
Results First Posted Date  ICMJE April 28, 2014
Last Update Posted Date April 28, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
Sum of Pain Intensity Differences (SPID) Over 48 Hours [ Time Frame: 48 hours ]
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
The sum of pain intensity difference at 48 hours (SPID48) relative to the first dose [ Time Frame: 48 hours ]
The sum of pain intensity difference is calculated based on the pain intensity 11-Point Numeric Rating Scale (NRS-11). It includes all observations from baseline to 48 hours. When using the NRS-11 patients are asked to rate their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
Change History Complete list of historical versions of study NCT01516008 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
  • Time to First Rescue Medication Use [ Time Frame: Up to 48 hours ]
    Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.
  • Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours [ Time Frame: Baseline (Day 1) and 12, 24, 48, and 72 hours ]
    Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
  • Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours [ Time Frame: 12, 24, 48, and 72 hours ]
    Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
  • Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours [ Time Frame: 12, 24, 48, and 72 hours ]
    Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
  • Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours [ Time Frame: 12, 24, and 72 hours ]
    Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.
  • Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours [ Time Frame: 12, 24, 48, and 72 hours ]
    Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.
  • Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours [ Time Frame: 12, 24, 48, and 72 hours ]
    Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.
  • Patient Global Impression of Change (PGI-C) Score at 72 Hours [ Time Frame: Baseline (Day 1) and 72 hours ]
    The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Time from first dose to the first use of rescue medication [ Time Frame: up to 72 hours ]
  • Percent change from baseline in pain intensity (PI) [ Time Frame: at baseline, 12, 24, 48 and 72 hours ]
    The pain intensity is calculated based on the pain intensity 11-Point Numeric Rating Scale (NRS-11). When using the NRS-11 patients are asked to rate their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
  • The sum of pain intensity difference (SPID) relative to the first dose [ Time Frame: at 12, 24, and 72 hours ]
    The sum of pain intensity difference is calculated based on the pain intensity 11-Point Numeric Rating Scale (NRS-11). When using the NRS-11 patients are asked to rate their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible".
  • The total pain relief (TOTPAR) [ Time Frame: at 12, 24, 48, and 72 hours ]
    The total pain relief is calcuated based on a 5-Point Numeric Rating Scale. The patients indicate how much relief they had from the starting pain on a scale from 0 to 4, where 0 represents "no relief" and 4 represents "complete relief".
  • The sum of total pain relief and sum of pain intensity difference (SPRID) [ Time Frame: at 12, 24, 48, and 72 hours ]
    The Sum of Total Pain Relief and Sum of Pain Intensity Difference is calculated using the following formula: SPRID = SPID + TOTPAR
  • The patient global impression of change (PGIC) [ Time Frame: at 72 hours ]
    The PGIC scale indicates what the patient overall status is. Patients are asked to rate their overall status on a scale from 1 to 7, where 1 represents "very much improved" and 7 represents "very much worse".
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 32 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy; Bridging Study for Korea
Brief Summary The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean patients with acute pain following bunionectomy.
Detailed Description This is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of tapentadol immediate-release (IR) 50 mg and 75 mg in patients who are undergoing bunionectomy (a surgical procedure to remove a bunion). This study was designed to be a similar study to the pivotal global study of PAI-3003/KF32 in order to bridge the results from the global studies and to show similarity in effect of tapentadol between Korean and Caucasian population which will allow extrapolation of the foreign clinical data of tapentadol into Korea. The study will be divided into screening period, surgical period, qualification period, and a double-blind treatment period. The study length, including the screening period, will be up to a maximum duration of 32 days. Eligible patients will be randomly assigned to 1 of 3 treatment groups (tapentadol IR 50 mg, tapentadol IR 75 mg or placebo) in a 1:1:1 ratio. Efficacy and safety assessments will be performed during the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Hallux Valgus
Intervention  ICMJE
  • Drug: Tapentadol IR 50 mg
    Type= exact number, unit= mg, number= 50, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.
  • Drug: Tapentadol IR 75 mg
    Type= exact number, unit= mg, number= 75, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.
  • Drug: Placebo
    Form= tablet, route= oral use. Placebo tablets will be administered as a single oral dose every 4 to 6 hours, for a period of 72 hours.
Study Arms  ICMJE
  • Experimental: Tapentadol IR 50 mg
    Intervention: Drug: Tapentadol IR 50 mg
  • Experimental: Tapentadol IR 75 mg
    Intervention: Drug: Tapentadol IR 75 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Lee YK, Ko JS, Rhim HY, Lee EJ, Karcher K, Li H, Shapiro D, Lee HS. Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea. Curr Med Res Opin. 2014 Dec;30(12):2561-70. doi: 10.1185/03007995.2014.954665. Epub 2014 Aug 27.

*   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: February 27, 2013)
353
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2012)
348
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who are undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only with or without the Akin procedure
  • Healthy or medically stable on the basis of clinical laboratory tests performed at screening. If results are outside the normal reference ranges, the patient may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
  • Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Women of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test before surgery
  • If a male and sexually active, agrees to use an approved method of birth control to prevent pregnancy in his female partner and not to donate sperm from the day of first study drug intake until 3 months after the day of last study drug intake. To qualify for entry into the double-blind treatment period, the following criteria must be met:
  • Qualifying baseline pain intensity (PI) must be rated as greater than or equal to 4 on an 11-point (0 to10) PI numerical rating scale (NRS), recorded within 30 minutes before randomization
  • Qualifying PI must occur no earlier than 10 hours after the first surgical incision
  • Qualifying baseline PI must occur within 9 hours after termination of the systemic analgesia during the postoperative surgical period

Exclusion Criteria:

  • History of seizure disorder or epilepsy suggested by the presence of mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, and/or severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, or posttraumatic amnesia of more than 24 hours duration within 15 years of screening
  • History of malignancy within the past 2 years before the start of the study
  • Evidence of active infections that may spread to other areas of the body or a history of human immunodeficiency virus 1 or 2
  • Clinical laboratory values reflecting severe renal insufficiency
  • Moderately or severely impaired hepatic function, or patients with abnormal alanine aminotransaminase or aspartate aminotransferase
  • Clinical laboratory values outside acceptable limits for surgery in the opinion of the investigator
  • A clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments
  • Treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or serotonin norepinephrine reuptake inhibitor within 2 weeks before randomization
  • Systemic steroid therapy, excluding inhalers or topical steroids, within the 4 weeks before screening
  • Women who plan to become pregnant during the study, or who are breast feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01516008
Other Study ID Numbers  ICMJE CR100459
R331333PAI3030 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date March 2014

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