Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents

Completed · Phase 2

Conditions studied: Pain, Postoperative, Postoperative Pain

In brief

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.

Key facts

Study ID

NCT01134536

Run by

Janssen Research & Development, LLC

People needed

45

Starts

2011-10-01

Expected to finish

2013-03-01

Last updated by the study team

2014-07-14

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Meridian, Idaho, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — The Bronx, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Hamilton, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Sherbrooke, Quebec, Canada
• Study site — F-75 730 Paris Cedex 15, France
• Study site — Rennes, France
• Study site — Madrid, Spain
• Study site — Valladolid, Spain

Full record on ClinicalTrials.gov

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