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

Chronic Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902837
• Other study ID #: OXN3503
• Secondary ID: 2008-002670-36
• Status: Completed
• Phase: Phase 3
• Start date: May 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2018
• Source: Mundipharma Research GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Osteoarthritis
• Constipation
• Osteoarthritis

Intervention

Drug:
• Oxycodone naloxone prolonged release tablets (OXN)

• oxycodone prolonged release tablet

• oxycodone naloxone tablet

Locations

Country	Name	City	State
Czechia	Dr R Flasar	Brno
Czechia	FN U Svate Anny	Brno
Czechia	Urazova nemocnice v Brne	Brno
Czechia	Dr E Lengalove	Ceske Budejovice
Czechia	Dr M Vdoviak	Karlovy Vary
Czechia	Nemocnice Most	Most
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Revmatologicka ambulance	Praha 10
Czechia	VFN Praha	Praha 2
Czechia	Dr Z Urbanova	Praha 4
Czechia	Revmatologicka ambulance	Praha 4
Czechia	Chirurgicke oddeleni	Praha 8
Czechia	FN Na Bulovce	Praha 8
Czechia	Revmatologicka ambul	Uherske Hradiste
Germany	Dr I Palutke	Bad Klosterlausnitz
Germany	Dr G Voss	Berlin
Germany	Schmerzzentrum Celle	Celle
Germany	Dr S Grunert	Eichstatt
Germany	Gemeinschaftspraxis fuer	Greifswald
Germany	Clinical Research	Hamburg
Germany	Praxis fur klinische Studien	Hamburg
Germany	Dr E A Lux	Lunen
Germany	Dr O Lowenstein	Mainz
Germany	Dr U Schutter	Marl
Germany	Dr H M Frick	Rhaunen
Germany	Prof Dr F Weber	Senftenberg
Germany	Dr U Krauspe	Weimar
Germany	Dr J Hafer	Wetzlar
Germany	Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit	Wiesbaden
Germany	Schmerz und Palliativzentrum	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research GmbH & Co KG

Countries where clinical trial is conducted

Belgium,  Czechia,  Finland,  Germany,  Hungary,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Text results available on website