Last updated on October 2017

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.


Brief description of study

Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain. During the first 2 weeks of the study (Part 1), participants will be given either tapentadol or morphine prolonged-release tablets. Assignment will be done randomly (like tossing a coin). The participant and the caregiver will know which medication they are taking. The primary endpoint is based on data collected in Part 1 of this trial. If eligible and willing, participants from Part 1 can enter a 12 month follow-up period (Part 2). In Part 2 of this trial participants will be treated with tapentadol prolonged release tablets or with the standard of care (observation arm).

Clinical Study Identifier: NCT02151682

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BE001

Leuven, Belgium
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BG005

Pleven, Bulgaria
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BG004

Plovdiv, Bulgaria
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BG001

Sofia, Bulgaria
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BG006

Sofia, Bulgaria
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CL004

Santiago, Chile
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CL003

Talcahuano, Chile
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CL001

Valparaíso, Chile
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HR001

Zagreb, Croatia
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FR008

Amiens, France
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FR004

Brest, France
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FR002

Lille, France
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FR006

Lyon, France
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FR005

Nice, France
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FR007

Toulouse, France
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FR001

Vandoeuvre les Nancy, France
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FR003

Villejuif Cedex, France
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DE007

Augsburg, Germany
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DE006

Dresden, Germany
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DE002

Erlangen, Germany
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DE005

Freiburg, Germany
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DE001

Homburg, Germany
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DE003

Mainz, Germany
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HU001

Budapest, Hungary
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HU002

Miskolc, Hungary
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IT009

Catania, Italy
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IT002

Genoa, Italy
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IT005

Napoli, Italy
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IT006

Roma, Italy
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IT003

Turin, Italy
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IT007

Verona, Italy
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MX001

Monterrey, Mexico
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PT001

Braga, Portugal
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PT003

Porto, Portugal
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PT002

Porto, Portugal
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SK001

Banska Bystrica, Slovakia
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Sl001

Ljubljana, Slovenia
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Sl002

Ljubljana, Slovenia
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ES001

Barcelona, Spain
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ES004

Barcelona, Spain
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ES002

Barcelona, Spain
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ES003

Valladolid, Spain
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CH001

Zürich, Switzerland
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GB005

Leeds, United Kingdom
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GB001

London, United Kingdom
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GB003

Manchester, United Kingdom
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GB006

Sheffield, United Kingdom
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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