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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00902837
First received: May 14, 2009
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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

Condition Intervention Phase
Chronic Osteoarthritis
Drug: Oxycodone naloxone prolonged release tablets (OXN)
Drug: oxycodone prolonged release tablet
Drug: oxycodone naloxone tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Research GmbH & Co KG:

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 [ Time Frame: End of 12 week study ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902837

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

Additional Information:
No publications provided

Responsible Party: Mundipharma Research GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00902837     History of Changes
Other Study ID Numbers: OXN3503, 2008-002670-36
Study First Received: May 14, 2009
Last Updated: December 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Mundipharma Research GmbH & Co KG:
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

Additional relevant MeSH terms:
Osteoarthritis
Constipation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014