OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects

Phase 3

Completed

• Conditions: Chronic Osteoarthritis
• Interventions: Drug: oxycodone prolonged release tablet; Drug: Oxycodone naloxone prolonged release tablets (OXN); Drug: oxycodone naloxone tablet

• Registration Number: NCT00902837
• Lead Sponsor: Mundipharma Research GmbH & Co KG

Brief Summary

The primary objectives are

* 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

Detailed Description

Subjects with moderate to severe pain due to osteoarthritis (OA) will be randomised to oxycodone/naloxone prolonged release (OXN PR) or oxycodone prolonged release tablets (OxyPR) alone 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 and to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation compared to subjects taking OxyPR alone.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxycodone naloxone tablet	oxycodone naloxone tablet	Oxycodone naloxone prolonged release tablets (OXN)
oxycodone Tablet	oxycodone prolonged release tablet	OxyCodone Prolonged release tablets
oxycodone naloxone tablet	Oxycodone naloxone prolonged release tablets (OXN)	Oxycodone naloxone prolonged release tablets (OXN)

Primary Outcome Measures

Name	Time	Method
To demonstrate that treatment with OXN PR tablets is non-inferior to treatment with OxyPR with regards to analgesic efficacy & locomotor function. To demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged re	End of 12 week study

Trial Locations

Locations (29)

Dr G Voss; 🇩🇪 Berlin, Germany

Dr M Vdoviak; 🇨🇿 Karlovy Vary, Czechia

Dr S Grunert; 🇩🇪 Eichstatt, Germany

Dr E Lengalove; 🇨🇿 Ceske Budejovice, Czechia

Nemocnice Most; 🇨🇿 Most, Czechia

Dr Z Urbanova; 🇨🇿 Praha 4, Czechia

Dr U Schutter; 🇩🇪 Marl, Germany

Dr R Flasar; 🇨🇿 Brno, Czechia

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

VFN Praha; 🇨🇿 Praha 2, Czechia

Chirurgicke oddeleni; 🇨🇿 Praha 8, Czechia

Dr I Palutke; 🇩🇪 Bad Klosterlausnitz, Germany

Dr O Lowenstein; 🇩🇪 Mainz, Germany

Revmatologicka ambulance; 🇨🇿 Praha 4, Czechia

FN Na Bulovce; 🇨🇿 Praha 8, Czechia

Dr H M Frick; 🇩🇪 Rhaunen, Germany

Dr U Krauspe; 🇩🇪 Weimar, Germany

Dr J Hafer; 🇩🇪 Wetzlar, Germany

Dr E A Lux; 🇩🇪 Lunen, Germany

Gemeinschaftspraxis fuer; 🇩🇪 Greifswald, Germany

Revmatologicka ambul; 🇨🇿 Uherske Hradiste, Czechia

Schmerzzentrum Celle; 🇩🇪 Celle, Germany

Schmerz und Palliativzentrum; 🇩🇪 Wiesbaden, Germany

Clinical Research; 🇩🇪 Hamburg, Germany

FN U Svate Anny; 🇨🇿 Brno, Czechia

Urazova nemocnice v Brne; 🇨🇿 Brno, Czechia

Praxis fur klinische Studien; 🇩🇪 Hamburg, Germany

Prof Dr F Weber; 🇩🇪 Senftenberg, Germany

Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit; 🇩🇪 Wiesbaden, Germany