A study to compare tapentadol to morphine in young people having pain
Research type
Research Study
Full title
An open label trial, enrolling subjects aged 6 years to less than 18 years suffering from pain requiring prolonged release opioid treatment, to evaluate the safety and efficacy of tapentadol PR versus morphine PR, followed by an open label extension.
IRAS ID
159170
Contact name
Richard Howard
Contact email
Sponsor organisation
Grünenthal GmbH
Eudract number
2012-004360-22
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
234525, Publication number; U1111-1154-4572, Universal Trial Number; PK1492, Pharmacokinetic study code
Research summary
This clinical trial study is to see how safely and effectively Tapentadol helps to reduce pain in young people compared to morphine. We are going to check this in young people aged from 6 years to less than 18 years who are suffering from an underlying long-term pain requiring opioid treatment. During the study, we are also going to find out how young people’s bodies process Tapentadol and what types of metabolites are being produced. Both Tapentadol and morphine are PR (prolonged release) tablets, which allow medication released slowly.
If young people (and their legal representative, if they are younger than 16 years old) decide to take part, they will take either Tapentadol or morphine for the first 2 weeks. This is Part 1 of the study where we compare the safety and effectiveness of Tapentadol and morphine. For every 3 participants, 2 of them will take Tapentadol and 1 of them will take morphine. We are going to take some additional blood samples from young people taking Tapentadol to find out how their bodies process Tapentadol and what types of metabolites are being produced.
After the 2 weeks, young people will continue for another 1 year to observe the longer safety of Tapentadol. This is Part 2 of the study. Participants may take Tapentadol (called Tapentadol Period) or they may not take anything (called Observational Period). Even if they are taking Tapentadol during Part 2, they can always stop taking it at any time and use other pain medications as needed.
We will check the participants’ health monthly whilst they are taking Tapentadol. If the participants are not taking Tapentadol, we will check their health every 3 months. If the participants were taking morphine in Part 1 and then start taking Tapentadol in Part 2, we will perform regular check-ups for 2 weeks for their safety. Each participant will be in the study for up to 13 months.
REC name
Scotland A REC
REC reference
14/SS/1026
Date of REC Opinion
2 Oct 2014
REC opinion
Further Information Favourable Opinion