CClinicalTrials.gg
Sign In
CompletedNCT00902837Updated Oct 22, 2018

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

A Phase 3 interventional study of Oxycodone naloxone prolonged release tablets (OXN) and oxycodone prolonged release tablet in Chronic Osteoarthritis, sponsored by Mundipharma Research GmbH & Co KG. Completed at 36 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by Mundipharma Research GmbH & Co KG · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • 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
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 181 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Mundipharma Research GmbH & Co KG is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
181 participants (actual)

Study arms

  • Active comparator
    oxycodone Tablet

    OxyCodone Prolonged release tablets

    Drug: oxycodone prolonged release tablet

  • Experimental
    oxycodone naloxone tablet

    Oxycodone naloxone prolonged release tablets (OXN)

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

Interventions

  • DrugOxycodone naloxone prolonged release tablets (OXN)
  • Drugoxycodone prolonged release tablet
  • Drugoxycodone naloxone tablet
06

What researchers measure

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

    Time frame: End of 12 week study

07

Study locations

36 sites
  • Gent, Belgium
  • Dr R Flasar
    Brno, 60200, Czechia
  • FN U Svate Anny
    Brno, 65691, Czechia
  • Urazova nemocnice v Brne
    Brno, 66250, Czechia
  • Dr E Lengalove
    Ceske Budejovice, 37087, Czechia
  • Dr M Vdoviak
    Karlovy Vary, 36001, Czechia
  • Nemocnice Most
    Most, 43464, Czechia
  • Fakultni nemocnice Olomouc
    Olomouc, 77520, Czechia
  • Plzen-Lochotin, 30460, Czechia
  • Revmatologicka ambulance
    Praha 10, 10100, Czechia
  • VFN Praha
    Praha 2, 12800, Czechia
  • Dr Z Urbanova
    Praha 4, 14000, Czechia
  • Revmatologicka ambulance
    Praha 4, 14000, Czechia
  • Chirurgicke oddeleni
    Praha 8, 18081, Czechia
  • FN Na Bulovce
    Praha 8, 18081, Czechia
  • Revmatologicka ambul
    Uherske Hradiste, 68668, Czechia
  • Kuopio, Finland
  • Dr I Palutke
    Bad Klosterlausnitz, 07639, Germany
  • Dr G Voss
    Berlin, 10559, Germany
  • Schmerzzentrum Celle
    Celle, 29221, Germany
  • Dr S Grunert
    Eichstatt, 85072, Germany
  • Gemeinschaftspraxis fuer
    Greifswald, 17489, Germany
  • Clinical Research
    Hamburg, 22143, Germany
  • Praxis fur klinische Studien
    Hamburg, 22415, Germany
  • Dr E A Lux
    Lunen, 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
  • 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
  • Mezokovesd, Hungary
  • Madrid, Spain
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00902837
Lead sponsor
Mundipharma Research GmbH & Co KG
Responsible party
Sponsor
First posted
May 15, 2009
Start date
May 2009
Primary completion
Apr 2010
Completion
Jul 2010
Last update
Oct 22, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoarthritis→

Other studies from this sponsor

Mundipharma Research GmbH & Co KG

Start the discussion