Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents
Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years
5 other identifiers
interventional
45
4 countries
17
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2011
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 14, 2014
July 1, 2014
1.4 years
May 28, 2010
July 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic profile
15 hours after the dose
Secondary Outcomes (2)
number of patients with adverse events as a measure of safety and tolerability
end of treatment (from 15 hours post treatment to discharge or early withdrawal)
Number of patients with adverse events as a measure of safety and tolerability
Up to 15 hours post treatment on Day 1
Study Arms (1)
Tapentadol Oral Solution (OS)
EXPERIMENTALInterventions
Tapentadol OS Bodyweight \<20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight \>=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.
Eligibility Criteria
You may qualify if:
- Parent(s) or the legal guardian(s) of the patient signed an informed consent document indicating that they understand the purpose of the study, the risks and benefits of the procedures required for the study and give permission for their child to participate in the study
- Physical status rated as I or II on the American Society of Anesthesiologists (ASA) rating scale
- Patient is alert, oriented, able to follow commands, able to understand the study requirements and procedures, and able to communicate intelligibly with the health care provider (taking into account his/her age)
- As per investigator's medical evaluation, patient is able to drink and tolerate oral fluids and medication
- Patient has a postoperative pain intensity score \>=4 on the McGrath Color Analog Scale (CAS) as a result of a scheduled surgical procedure or if in the investigator's clinical judgment (ie, investigator judgment relying on standard of care rather than the McGrath CAS), the patient has a pain level that the standard of care following the surgical procedure (which reliably produces moderate to severe pain) requires opioid treatment
You may not qualify if:
- History of seizure disorder or epilepsy, or serotonin syndrome, or mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or severe traumatic brain injury within 15 years of screening, or any traumatic or hypoxic brain injury resulting in ongoing sequelae suggesting transient changes in consciousness
- Moderate to severe renal or hepatic impairment
- Requires concomitant use of sedatives, other than those used during surgery
- Has received dextromethorphan within 2 days before the scheduled study drug administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Grünenthal GmbHcollaborator
Study Sites (17)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Unknown Facility
F-75 730 Paris Cedex 15, France
Unknown Facility
Rennes, France
Unknown Facility
Madrid, Spain
Unknown Facility
Valladolid, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC C. Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
October 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 14, 2014
Record last verified: 2014-07