A study to look at Tapentadol Liquid in Children & Adolescents in pain
Research type
Research Study
Full title
An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 years old.
IRAS ID
149080
Contact name
Ayman Eissa
Contact email
Sponsor organisation
Janssen Research & Development
Eudract number
2012-004359-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
R331333PAI3037, Janssen Protocol Number; KF5503/65, Grunenthal Protocol Number
Research summary
Acute pain in post-surgery patients is usually treated with medication known as opioid drugs. Tapentadol is a strong pain medication known to be effective in adults and is in the same drug class as morphine (opioids).Tapentadol oral solution is currently approved for use in adult patients, but not yet in children.
The primary purpose of this research study is to assess how well tapentadol oral solution treats pain in children aged from birth to <18 years old inclusive, by looking at how much additional pain control children require in addition to tapentadol, compared to children who receive a placebo (dummy medication) instead of tapentadol.
The secondary purpose of this trial is to evaluate the safety of tapentadol in children.
Approximately 168 children will be enrolled and will receive trial medication. There will be about 50 centres world-wide participating in the trial.
The study is randomised and double-blind, which means neither the participant nor the study doctor, will know which medication the participant is assigned to. Participants will be allocated randomly to either the tapentadol or placebo group in a 2:1 ratio.
The participant will receive trial medication for 2 days, but may be in the trial for up to about 7 weeks due to enrolment and follow up procedures. The stay in the hospital will not be longer than it would be without being in the study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/1037
Date of REC Opinion
5 Sep 2014
REC opinion
Further Information Favourable Opinion