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: July 8, 2013
Last verified: July 2013
  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:
  • The sum of pain intensity difference at 48 hours (SPID48) relative to the first dose [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • Time from first dose to the first use of rescue medication [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
  • Percent change from baseline in pain intensity (PI) [ Time Frame: at baseline, 12, 24, 48 and 72 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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
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
Last Updated: July 8, 2013
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:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014