A Phase 2 interventional study of Tapentadol (OS) Oral Solution in Pain, Postoperative and Postoperative Pain, sponsored by Janssen Research & Development, LLC. Completed at 18 sites in 4 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2014-07-14.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
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.
This is a multicenter, single-arm, open-label (all people involved know the identity of the intervention), single-dose study to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time), safety and tolerability of tapentadol 1 mg/kg oral solution (OS) in children aged from 6 to less than 18 years after scheduled surgical procedures that routinely produce acute, moderate to severe postsurgical pain. A screening phase, as per standard of care but not exceeding 30 days, will include the preoperative evaluation, the surgical procedure and its immediate post recovery, and will be followed by the open-label treatment phase and end-of-study assessments. Study drug administration will take place after the surgery has been completed, when the patient is alert, orientated, able to follow commands and complete the required postoperative procedures, and able to tolerate fluid and medication orally. Confinement to the study center for a patient will be as per standard of care, and will include the surgery, the entire 15-hour postdose evaluation period and the end-of-study evaluations. Children with a body weight less than 20 kg will be dosed with a single dose of tapentadol 4 mg/mL OS and children with a body weight of 20 kg or greater will be dosed with a single dose of tapentadol 20 mg/mL OS.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 45 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Exclusion Criteria:
Drug: Tapentadol (OS) Oral Solution
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.
Pharmacokinetic profile
Time frame: 15 hours after the dose
number of patients with adverse events as a measure of safety and tolerability
Time frame: 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
Time frame: Up to 15 hours post treatment on Day 1
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC