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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01516008
First received: January 19, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hallux Valgus
Drug: Tapentadol IR 50 mg
Drug: Tapentadol IR 75 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Sum of Pain Intensity Differences (SPID) Over 48 Hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to First Rescue Medication Use [ Time Frame: Up to 48 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 353
Study Start Date: January 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tapentadol IR 50 mg 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.
Experimental: Tapentadol IR 75 mg 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.
Placebo Comparator: Placebo 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516008

Locations
Korea, Republic of
Busan, Korea, Republic of
Chungcheongbuk-Do, Korea, Republic of
Gwangju, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Ulsan, Korea, Republic of
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01516008     History of Changes
Other Study ID Numbers: CR100459, R331333PAI3030
Study First Received: January 19, 2012
Results First Received: January 24, 2014
Last Updated: March 28, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Hallux Valgus
Bunionectomy
Bunion
Acute pain
Tapentadol
Tapentadol IR

Additional relevant MeSH terms:
Acute Pain
Hallux Valgus
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014