216
Participants
Start Date
February 19, 2015
Primary Completion Date
March 3, 2019
Study Completion Date
March 14, 2019
Tapentadol oral solution 4 mg/mL
"Participants aged 6 months to less than 18 years old with a body weight below 20 kg received tapentadol oral solution 4 mg/mL by mouth every 4 hours for up to 72 hours.~Participants from birth to less than 6 months received tapentadol oral solution, diluted 4 fold."
Tapentadol oral solution 20 mg/mL
Participants aged from 6 months to less than 18 years with a body weight greater than or equal to 20 kg received tapentadol oral solution 20 mg/mL by mouth every 4 hours for up to 72 hours.
Placebo
Matching placebo oral solution was administered by mouth every 4 hours up to 72 hours.
BG002, Stara Zagora
HU004, Budapest
BG005, Sofia
HU003, Debrecen
BG003, Pleven
ES002, Barcelona
HR001, Zagreb
US001, The Bronx
US018, The Bronx
CZ001, Praha 4 - Krč
US014, Pittsburgh
ES009, Santiago de Compostela
US015, Philadelphia
HR003, Split
US006, Durham
ES005, Madrid
ES007, Madrid
US011, Miami
FR002, La Tronche
US012, Louisville
US016, Cincinnati
ES006, Valladolid
US007, Milwaukee
FR001, Lille
US008, Little Rock
CZ004, Fryštát
US003, Dallas
US005, Houston
CZ003, Olomouc
DE001, Freiburg im Breisgau
FR004, Limoges
US004, Stanford
PL011, Bydgoszcz
PL010, Gdansk
PL005, Lodz
PL002, Lublin
PL009, Olsztyn
PL014, Rzeszów
PL007, Torun
PL004, Warsaw
PL008, Warsaw
GB003, Bristol
GB001, Sheffield
Lead Sponsor
Collaborators (1)
Depomed
INDUSTRY
Grünenthal GmbH
INDUSTRY