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

Condition(s) targeted: Chronic Osteoarthritis

Intervention: Oxycodone naloxone prolonged release tablets (OXN) (Drug); oxycodone prolonged release tablet (Drug); oxycodone naloxone tablet (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mundipharma Research GmbH & Co KG

Overall contact:
Margaret C Wilson, Phone: 01223 424900, Email: info@contact-clinical-trials.com

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

Official title: Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee &/or Hip Taking Oxycodone Equivalent of 20 - 80 mg/Day as Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Subjects Taking Oxycodone Prolonged Release Tablets (OxyPR) Alone.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid

therapy.

Exclusion criteria:

- Females who are pregnant or lactating.

- Subjects with evidence of significant structural abnormalities of the

gastrointestinal tract.

- Subjects with evidence of impaired liver/kidney function upon entry into the study

Margaret C Wilson, Phone: 01223 424900, Email: info@contact-clinical-trials.com

Fakultni nemocnice Olomouc, Olomouc 77520, Czech Republic; Not yet recruiting

Revmatologicka ambul, Uherske Hradiste 68668, Czech Republic; Not yet recruiting

Dr R Flasar, Brno 60200, Czech Republic; Not yet recruiting

FN U Svate Anny, Brno 65691, Czech Republic; Not yet recruiting

Urazova nemocnice v Brne, Brno 66250, Czech Republic; Not yet recruiting

Dr E Lengalove, Ceske Budejovice 37087, Czech Republic; Not yet recruiting

FN Plzen, Plzen 30460, Czech Republic; Not yet recruiting

Dr M Vdoviak, Karlovy Vary 36001, Czech Republic; Not yet recruiting

Nemocnice Most, Most 43464, Czech Republic; Not yet recruiting

Dr Z Urbanova, Praha 4 14000, Czech Republic; Not yet recruiting

VFN Praha, Praha 2 12800, Czech Republic; Not yet recruiting

FN Na Bulovce, Praha 8 18081, Czech Republic; Not yet recruiting

Chirurgicke oddeleni, Praha 8 18081, Czech Republic; Not yet recruiting

Revmatologicka ambulance, Praha 4 14000, Czech Republic; Not yet recruiting

Revmatologicka ambulance, Praha 10 10100, Czech Republic; Not yet recruiting

Prof Dr Friedemann Webber, Senftenberg 01968, Germany; Recruiting

Gemeinschaftspraxis fuer, Greifswald 17489, Germany; Not yet recruiting

Praxis fur klinische Studien, Hamburg 22415, Germany; Not yet recruiting

Schmerzzentrum Celle, Celle 29221, Germany; Not yet recruiting

Dr H M Frick, Rhaunen 55624, Germany; Not yet recruiting

Dr S Grunert, Eichstatt 85072, Germany; Not yet recruiting

Clinical Research, Hamburg 22143, Germany; Not yet recruiting

Dr U Krauspe, Weimar 99425, Germany; Not yet recruiting

Dr O Lowenstein, Mainz 55116, Germany; Not yet recruiting

Dr E A Lux, Lunen 44534, Germany; Not yet recruiting

Dr I Palutke, Bad Klosterlausnitz 07639, Germany; Not yet recruiting

Dr U Schutter, Marl 45768, Germany; Not yet recruiting

Schmerz und Palliativzentrum, Wiesbaden 65189, Germany; Not yet recruiting

Dr G Voss, Berlin 10559, Germany; Not yet recruiting

Prof Dr F Weber, Senftenberg 01968, Germany; Not yet recruiting

Dr J Hafer, Wetzlar 35578, Germany; Not yet recruiting

Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit, Wiesbaden 65185, Germany; Not yet recruiting

Rambam Medical Center, Haifa 31096, Israel; Not yet recruiting

Tel Aviv Sourasky Medical Center, Tel Aviv 64239, Israel; Not yet recruiting

Sheba Medical Center, Tel Hashomer 52621, Israel; Not yet recruiting

Hadassah Medical Center, Jerusalem 91120, Israel; Not yet recruiting

Starting date: May 2009
Ending date: July 2010
Last updated: August 26, 2009