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

Primary Purpose

Chronic Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oxycodone naloxone prolonged release tablets (OXN)
oxycodone prolonged release tablet
oxycodone naloxone tablet
Sponsored by
Mundipharma Research GmbH & Co KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Osteoarthritis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr R Flasar
  • FN U Svate Anny
  • Urazova nemocnice v Brne
  • Dr E Lengalove
  • Dr M Vdoviak
  • Nemocnice Most
  • Fakultni nemocnice Olomouc
  • Revmatologicka ambulance
  • VFN Praha
  • Dr Z Urbanova
  • Revmatologicka ambulance
  • Chirurgicke oddeleni
  • FN Na Bulovce
  • Revmatologicka ambul
  • Dr I Palutke
  • Dr G Voss
  • Schmerzzentrum Celle
  • Dr S Grunert
  • Gemeinschaftspraxis fuer
  • Clinical Research
  • Praxis fur klinische Studien
  • Dr E A Lux
  • Dr O Lowenstein
  • Dr U Schutter
  • Dr H M Frick
  • Prof Dr F Weber
  • Dr U Krauspe
  • Dr J Hafer
  • Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit
  • Schmerz und Palliativzentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

oxycodone Tablet

oxycodone naloxone tablet

Arm Description

OxyCodone Prolonged release tablets

Oxycodone naloxone prolonged release tablets (OXN)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 14, 2009
Last Updated
October 19, 2018
Sponsor
Mundipharma Research GmbH & Co KG
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1. Study Identification

Unique Protocol Identification Number
NCT00902837
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Research GmbH & Co KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxycodone Tablet
Arm Type
Active Comparator
Arm Description
OxyCodone Prolonged release tablets
Arm Title
oxycodone naloxone tablet
Arm Type
Experimental
Arm Description
Oxycodone naloxone prolonged release tablets (OXN)
Intervention Type
Drug
Intervention Name(s)
Oxycodone naloxone prolonged release tablets (OXN)
Intervention Type
Drug
Intervention Name(s)
oxycodone prolonged release tablet
Intervention Type
Drug
Intervention Name(s)
oxycodone naloxone tablet
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Gent
Country
Belgium
Facility Name
Dr R Flasar
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
FN U Svate Anny
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Urazova nemocnice v Brne
City
Brno
ZIP/Postal Code
66250
Country
Czechia
Facility Name
Dr E Lengalove
City
Ceske Budejovice
ZIP/Postal Code
37087
Country
Czechia
Facility Name
Dr M Vdoviak
City
Karlovy Vary
ZIP/Postal Code
36001
Country
Czechia
Facility Name
Nemocnice Most
City
Most
ZIP/Postal Code
43464
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
City
Plzen-Lochotin
ZIP/Postal Code
30460
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Praha 10
ZIP/Postal Code
10100
Country
Czechia
Facility Name
VFN Praha
City
Praha 2
ZIP/Postal Code
12800
Country
Czechia
Facility Name
Dr Z Urbanova
City
Praha 4
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Praha 4
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Chirurgicke oddeleni
City
Praha 8
ZIP/Postal Code
18081
Country
Czechia
Facility Name
FN Na Bulovce
City
Praha 8
ZIP/Postal Code
18081
Country
Czechia
Facility Name
Revmatologicka ambul
City
Uherske Hradiste
ZIP/Postal Code
68668
Country
Czechia
City
Kuopio
Country
Finland
Facility Name
Dr I Palutke
City
Bad Klosterlausnitz
ZIP/Postal Code
07639
Country
Germany
Facility Name
Dr G Voss
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
Schmerzzentrum Celle
City
Celle
ZIP/Postal Code
29221
Country
Germany
Facility Name
Dr S Grunert
City
Eichstatt
ZIP/Postal Code
85072
Country
Germany
Facility Name
Gemeinschaftspraxis fuer
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Facility Name
Clinical Research
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Praxis fur klinische Studien
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Dr E A Lux
City
Lunen
ZIP/Postal Code
44534
Country
Germany
Facility Name
Dr O Lowenstein
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Dr U Schutter
City
Marl
ZIP/Postal Code
45768
Country
Germany
Facility Name
Dr H M Frick
City
Rhaunen
ZIP/Postal Code
55624
Country
Germany
Facility Name
Prof Dr F Weber
City
Senftenberg
ZIP/Postal Code
01968
Country
Germany
City
Senftenberg
ZIP/Postal Code
01968
Country
Germany
Facility Name
Dr U Krauspe
City
Weimar
ZIP/Postal Code
99425
Country
Germany
Facility Name
Dr J Hafer
City
Wetzlar
ZIP/Postal Code
35578
Country
Germany
Facility Name
Intermed Institue fur Medizinische Forschung & Arzneimittelsicherheit
City
Wiesbaden
ZIP/Postal Code
65185
Country
Germany
Facility Name
Schmerz und Palliativzentrum
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
City
Mezokovesd
Country
Hungary
City
Madrid
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=OXN3503
Description
Text results available on website

Learn more about this trial

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

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