OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
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.
2 other identifiers
interventional
181
6 countries
36
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2009
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedOctober 22, 2018
October 1, 2018
11 months
May 14, 2009
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
oxycodone Tablet
ACTIVE COMPARATOROxyCodone Prolonged release tablets
oxycodone naloxone tablet
EXPERIMENTALOxycodone naloxone prolonged release tablets (OXN)
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to severe chronic nonmalignant OA and that require around-the-clock opioid therapy.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Ghent, Belgium
Dr R Flasar
Brno, 60200, Czechia
FN U Svate Anny
Brno, 65691, Czechia
Urazova nemocnice v Brne
Brno, 66250, Czechia
Dr E Lengalove
České Budějovice, 37087, Czechia
Dr M Vdoviak
Karlovy Vary, 36001, Czechia
Nemocnice Most
Most, 43464, Czechia
Fakultni nemocnice Olomouc
Olomouc, 77520, Czechia
Unknown Facility
Plzen-Lochotin, 30460, Czechia
Revmatologicka ambulance
Prague, 10100, Czechia
VFN Praha
Prague, 12800, Czechia
Dr Z Urbanova
Prague, 14000, Czechia
Revmatologicka ambulance
Prague, 14000, Czechia
Chirurgicke oddeleni
Prague, 18081, Czechia
FN Na Bulovce
Prague, 18081, Czechia
Revmatologicka ambul
Uherské Hradiště, 68668, Czechia
Unknown Facility
Kuopio, Finland
Dr I Palutke
Bad Klosterlausnitz, 07639, Germany
Dr G Voss
Berlin, 10559, Germany
Schmerzzentrum Celle
Celle, 29221, Germany
Dr S Grunert
Eichstätt, 85072, Germany
Gemeinschaftspraxis fuer
Greifswald, 17489, Germany
Clinical Research
Hamburg, 22143, Germany
Praxis fur klinische Studien
Hamburg, 22415, Germany
Dr E A Lux
Lünen, 44534, Germany
Dr O Lowenstein
Mainz, 55116, Germany
Dr U Schutter
Marl, 45768, Germany
Dr H M Frick
Rhaunen, 55624, Germany
Prof Dr F Weber
Senftenberg, 01968, Germany
Unknown Facility
Senftenberg, 01968, Germany
Dr U Krauspe
Weimar, 99425, Germany
Dr J Hafer
Wetzlar, 35578, Germany
Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit
Wiesbaden, 65185, Germany
Schmerz und Palliativzentrum
Wiesbaden, 65189, Germany
Unknown Facility
Mezőkövesd, Hungary
Unknown Facility
Madrid, Spain
Related Links
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 15, 2009
Study Start
May 1, 2009
Primary Completion
April 1, 2010
Study Completion
July 1, 2010
Last Updated
October 22, 2018
Record last verified: 2018-10