OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
NCT ID: NCT00902837
Last Updated: 2018-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
181 participants
INTERVENTIONAL
2009-05-31
2010-07-31
Brief Summary
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* to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function.
* to demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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oxycodone Tablet
OxyCodone Prolonged release tablets
oxycodone prolonged release tablet
oxycodone naloxone tablet
Oxycodone naloxone prolonged release tablets (OXN)
Oxycodone naloxone prolonged release tablets (OXN)
oxycodone naloxone tablet
Interventions
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Oxycodone naloxone prolonged release tablets (OXN)
oxycodone prolonged release tablet
oxycodone naloxone tablet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study
18 Years
ALL
No
Sponsors
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Mundipharma Research GmbH & Co KG
INDUSTRY
Responsible Party
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Locations
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Ghent, , Belgium
Dr R Flasar
Brno, , Czechia
FN U Svate Anny
Brno, , Czechia
Urazova nemocnice v Brne
Brno, , Czechia
Dr E Lengalove
České Budějovice, , Czechia
Dr M Vdoviak
Karlovy Vary, , Czechia
Nemocnice Most
Most, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Plzen-Lochotin, , Czechia
Revmatologicka ambulance
Prague, , Czechia
VFN Praha
Prague, , Czechia
Dr Z Urbanova
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Chirurgicke oddeleni
Prague, , Czechia
FN Na Bulovce
Prague, , Czechia
Revmatologicka ambul
Uherské Hradiště, , Czechia
Kuopio, , Finland
Dr I Palutke
Bad Klosterlausnitz, , Germany
Dr G Voss
Berlin, , Germany
Schmerzzentrum Celle
Celle, , Germany
Dr S Grunert
Eichstätt, , Germany
Gemeinschaftspraxis fuer
Greifswald, , Germany
Clinical Research
Hamburg, , Germany
Praxis fur klinische Studien
Hamburg, , Germany
Dr E A Lux
Lünen, , Germany
Dr O Lowenstein
Mainz, , Germany
Dr U Schutter
Marl, , Germany
Dr H M Frick
Rhaunen, , Germany
Prof Dr F Weber
Senftenberg, , Germany
Senftenberg, , Germany
Dr U Krauspe
Weimar, , Germany
Dr J Hafer
Wetzlar, , Germany
Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit
Wiesbaden, , Germany
Schmerz und Palliativzentrum
Wiesbaden, , Germany
Mezőkövesd, , Hungary
Madrid, , Spain
Countries
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Related Links
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Text results available on website
Other Identifiers
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2008-002670-36
Identifier Type: -
Identifier Source: secondary_id
OXN3503
Identifier Type: -
Identifier Source: org_study_id
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