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

October 19, 2018 updated by: Mundipharma Research GmbH & Co KG

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium
  • Czechia
      • Brno, Czechia, 60200
        • Dr R Flasar
      • Brno, Czechia, 65691
        • FN U Svate Anny
      • Brno, Czechia, 66250
        • Urazova nemocnice v Brne
      • Ceske Budejovice, Czechia, 37087
        • Dr E Lengalove
      • Karlovy Vary, Czechia, 36001
        • Dr M Vdoviak
      • Most, Czechia, 43464
        • Nemocnice Most
      • Olomouc, Czechia, 77520
        • Fakultní Nemocnice Olomouc
      • Plzen-Lochotin, Czechia, 30460
      • Praha 10, Czechia, 10100
        • Revmatologicka ambulance
      • Praha 2, Czechia, 12800
        • VFN Praha
      • Praha 4, Czechia, 14000
        • Revmatologicka ambulance
      • Praha 4, Czechia, 14000
        • Dr Z Urbanova
      • Praha 8, Czechia, 18081
        • Chirurgicke oddeleni
      • Praha 8, Czechia, 18081
        • FN Na Bulovce
      • Uherske Hradiste, Czechia, 68668
        • Revmatologicka ambul
  • Finland
      • Kuopio, Finland
  • Germany
      • Bad Klosterlausnitz, Germany, 07639
        • Dr I Palutke
      • Berlin, Germany, 10559
        • Dr G Voss
      • Celle, Germany, 29221
        • Schmerzzentrum Celle
      • Eichstatt, Germany, 85072
        • Dr S Grunert
      • Greifswald, Germany, 17489
        • Gemeinschaftspraxis fuer
      • Hamburg, Germany, 22143
        • Clinical research
      • Hamburg, Germany, 22415
        • Praxis fur klinische Studien
      • Lunen, Germany, 44534
        • Dr E A Lux
      • Mainz, Germany, 55116
        • Dr O Lowenstein
      • Marl, Germany, 45768
        • Dr U Schutter
      • Rhaunen, Germany, 55624
        • Dr H M Frick
      • Senftenberg, Germany, 01968
        • Prof Dr F Weber
      • Senftenberg, Germany, 01968
      • Weimar, Germany, 99425
        • Dr U Krauspe
      • Wetzlar, Germany, 35578
        • Dr J Hafer
      • Wiesbaden, Germany, 65185
        • Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit
      • Wiesbaden, Germany, 65189
        • Schmerz und Palliativzentrum
  • Hungary
      • Mezokovesd, Hungary
  • Spain
      • Madrid, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
End of 12 week study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma Research GmbH & Co KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (ESTIMATE)

May 15, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXN3503
  • 2008-002670-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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