Clinical trial NCT00902837: OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Osteoarthritis
Keywords: randomised
double-blind
double-dummy
parallel-group
non-inferiority
pain locomotor function
improvement in symptoms of constipation
moderate to severe pain due to osteoarthritis (OA)
OXN PR
OxyPR
Moderate to severe chronic nonmalignant OA
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: End of 12 week study
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
city: Brno
country: Czechia
facility: Dr R Flasar
city: Brno
country: Czechia
facility: FN U Svate Anny
city: Brno
country: Czechia
facility: Urazova nemocnice v Brne
city: Ceske Budejovice
country: Czechia
facility: Dr E Lengalove
city: Karlovy Vary
country: Czechia
facility: Dr M Vdoviak
city: Most
country: Czechia
facility: Nemocnice Most
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Plzen-Lochotin
country: Czechia
city: Praha 10
country: Czechia
facility: Revmatologicka ambulance
city: Praha 2
country: Czechia
facility: VFN Praha
city: Praha 4
country: Czechia
facility: Dr Z Urbanova
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Praha 8
country: Czechia
facility: Chirurgicke oddeleni
city: Praha 8
country: Czechia
facility: FN Na Bulovce
city: Uherske Hradiste
country: Czechia
facility: Revmatologicka ambul
city: Kuopio
country: Finland
city: Bad Klosterlausnitz
country: Germany
facility: Dr I Palutke
city: Berlin
country: Germany
facility: Dr G Voss
city: Celle
country: Germany
facility: Schmerzzentrum Celle
city: Eichstatt
country: Germany
facility: Dr S Grunert
city: Greifswald
country: Germany
facility: Gemeinschaftspraxis fuer
city: Hamburg
country: Germany
facility: Clinical Research
city: Hamburg
country: Germany
facility: Praxis fur klinische Studien
city: Lunen
country: Germany
facility: Dr E A Lux
city: Mainz
country: Germany
facility: Dr O Lowenstein
city: Marl
country: Germany
facility: Dr U Schutter
city: Rhaunen
country: Germany
facility: Dr H M Frick
city: Senftenberg
country: Germany
facility: Prof Dr F Weber
city: Senftenberg
country: Germany
city: Weimar
country: Germany
facility: Dr U Krauspe
city: Wetzlar
country: Germany
facility: Dr J Hafer
city: Wiesbaden
country: Germany
facility: Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit
city: Wiesbaden
country: Germany
facility: Schmerz und Palliativzentrum
city: Mezokovesd
country: Hungary
city: Madrid
country: Spain
Study officials:
References: