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Chronic OsteoarthritisPhase 3NCT00902837

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

A Phase 3 study testing Oxycodone naloxone prolonged release tablets (OXN), oxycodone prolonged release tablet and oxycodone naloxone tablet in people with Chronic Osteoarthritis, run by Mundipharma Research GmbH & Co KG at 36 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Osteoarthritis
What is being tested?
Oxycodone naloxone prolonged release tablets (OXN), oxycodone prolonged release tablet and oxycodone naloxone tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
36 sitesin 6 countries
Study dates
May 2009to Jul 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

36 sites in 6 countries.

36 sites in 6 countries

Germany17 sites

  • Dr I Palutke

    Bad Klosterlausnitz, 07639

  • Dr G Voss

    Berlin, 10559

  • Schmerzzentrum Celle

    Celle, 29221

  • Dr S Grunert

    Eichstätt, 85072

  • Gemeinschaftspraxis fuer

    Greifswald, 17489

  • Clinical Research

    Hamburg, 22143

  • Praxis fur klinische Studien

    Hamburg, 22415

  • Dr E A Lux

    Lünen, 44534

  • Dr O Lowenstein

    Mainz, 55116

  • Dr U Schutter

    Marl, 45768

  • Dr H M Frick

    Rhaunen, 55624

  • Prof Dr F Weber

    Senftenberg, 01968

  • Study site

    Senftenberg, 01968

  • Dr U Krauspe

    Weimar, 99425

  • Dr J Hafer

    Wetzlar, 35578

  • Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit

    Wiesbaden, 65185

  • Schmerz und Palliativzentrum

    Wiesbaden, 65189

Other trials in Germany

Czechia15 sites

  • Dr R Flasar

    Brno, 60200

  • FN U Svate Anny

    Brno, 65691

  • Urazova nemocnice v Brne

    Brno, 66250

  • Dr E Lengalove

    České Budějovice, 37087

  • Dr M Vdoviak

    Karlovy Vary, 36001

  • Nemocnice Most

    Most, 43464

  • Fakultni nemocnice Olomouc

    Olomouc, 77520

  • Study site

    Plzen-Lochotin, 30460

  • Revmatologicka ambulance

    Prague, 10100

  • VFN Praha

    Prague, 12800

  • Dr Z Urbanova

    Prague, 14000

  • Revmatologicka ambulance

    Prague, 14000

  • Chirurgicke oddeleni

    Prague, 18081

  • FN Na Bulovce

    Prague, 18081

  • Revmatologicka ambul

    Uherské Hradiště, 68668

Other trials in Czechia

Belgium1 site

  • Study site

    Ghent

Other trials in Belgium

Finland1 site

  • Study site

    Kuopio

Other trials in Finland

Hungary1 site

  • Study site

    Mezőkövesd

Other trials in Hungary

Spain1 site

  • Study site

    Madrid

Other trials in Spain

About this study

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.

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.

Being tested
Oxycodone naloxone prolonged release tablets (OXN), oxycodone prolonged release tablet, oxycodone naloxone tablet
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone naloxone prolonged release tablets (OXN)Drug

  • oxycodone prolonged release tabletDrug

  • oxycodone naloxone tabletDrug

Study groups in NCT00902837
Study groupRoleWhat they receive
oxycodone TabletActive comparatorOxyCodone Prolonged release tablets
Receives: Drug: oxycodone prolonged release tablet
oxycodone naloxone tabletExperimentalOxycodone naloxone prolonged release tablets (OXN)
Receives: Drug: Oxycodone naloxone prolonged release tablets (OXN); Drug: oxycodone naloxone tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: End of 12 week study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionApr 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00902837
Sponsor's protocol ID
OXN3503
Other IDs
2008-002670-36, 2008
Status last verified
Oct 2018
First submitted
14 May 2009
Last updated
22 Oct 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxycodone naloxone prolonged release tablets (OXN), oxycodone prolonged release tablet and oxycodone naloxone tablet in people with Chronic Osteoarthritis, run by Mundipharma Research GmbH & Co KG at 36 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Germany, Czechia, Belgium, Finland, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: End of 12 week study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00902837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.

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