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

NCT01516008 | Completed Phase 3 Results

• 2 other identifiers: CR100459R331333PAI3030
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 7

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.

Conditions

Hallux Valgus

Keywords

Hallux Valgus; Bunionectomy; Bunion; Acute pain; Tapentadol; Tapentadol IR

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Differences (SPID) Over 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.

  48 hours

Secondary Outcomes (8)

• Time to First Rescue Medication Use

  Up to 48 hours

• Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours

  Baseline (Day 1) and 12, 24, 48, and 72 hours

• Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours

  12, 24, 48, and 72 hours

• Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours

  12, 24, 48, and 72 hours

• Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours

  12, 24, and 72 hours

Study Arms (3)

Tapentadol IR 50 mg

EXPERIMENTAL

Drug: Tapentadol IR 50 mg

Tapentadol IR 75 mg

EXPERIMENTAL

Drug: Tapentadol IR 75 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tapentadol IR 50 mg DRUG

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.

Tapentadol IR 50 mg

Tapentadol IR 75 mg DRUG

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.

Tapentadol IR 75 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (7)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Chungcheongbuk-Do, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Pusan, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Ulsan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25133962 DERIVED

MeSH Terms

Conditions

Hallux Valgus; Bunion; Acute Pain

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Leader
• Organization: Janssen Research & Development, L.L.C.

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 28, 2014
• Results First Posted: April 28, 2014

Record last verified: 2014-03

Locations

KR (7)